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What changed 10-K

Item 9A. Controls and Procedures

2026-03-26 compared with 2025-03-31 · 640 added, 567 removed, 802 unchanged (60% of the section changed)

6 unchanged sentences

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rule 13a-15(f) of the Exchange Act).

Our internal control over financial reporting

is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.

Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements.

10 unchanged sentences

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item will be included in the Company's 2025 Proxy Statement and is incorporated in this report by reference.

The information required by this item will be included in the 2026 Proxy Statement and is incorporated in this report by reference.

EXECUTIVE COMPENSATION

The information required by this item will be included in the Company's 2025 Proxy Statement and is incorporated in this report by reference.

The information required by this item will be included in the 2026 Proxy Statement and is incorporated in this report by reference, except as to information disclosed in the 2026 Proxy Statement pursuant to Item 402(v) of Regulation S-K relating to pay versus performance.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this item will be included in the Company's 2025 Proxy Statement and is incorporated in this report by reference.

The information required by this item will be included in the 2026 Proxy Statement and is incorporated in this report by reference.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this item will be included in the Company's 2025 Proxy Statement and is incorporated in this report by reference.

The information required by this item will be included in the 2026 Proxy Statement and is incorporated in this report by reference.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this item will be included in the Company's 2025 Proxy Statement and is incorporated in this report by reference.

The information required by this item will be included in the 2026 Proxy Statement and is incorporated in this report by reference.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

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10-Q 001-36395 08/12/2024 3.1

Certificate of Correction of the Certificate of Amendment of Restated Certificate of Incorporation dated June 21, 2024

06/27/2024 3.2

3.2 Third Amended and Restated By-Laws (as amended through January 24, 2023)

10 unchanged sentences

4.5 Description of securities of the registrant

10-K 001-36395 03/27/2020 4.6

COMMERCIAL AGREEMENTS

49 unchanged sentences

10-Q 001-36395 11/10/2021 10.1

10.8+ License Agreement dated as of January 10, 2020 between Bayer HealthCare LLC and Daré Bioscience, Inc.

10-K 001-36395 03/27/2020 10.16

10.8+ Cooperative Research and Development Agreement entered into as of July 8, 2021 between Daré Bioscience, Inc.

1 unchanged sentence

10-Q 001-36395 11/10/2021 10.2

L icense Agreement dated as of August 12, 2023 b etween Douglas Pharmaceuticals Limited and Daré Bioscience, Inc.

10.9+ License Agreement dated as of August 12, 2023 between Douglas Pharmaceuticals Limited and Daré Bioscience, Inc.

03/31/2025 10.10

10.10+ Grant Agreement between Daré Bioscience, Inc.

2 unchanged sentences

and the Bill & Melinda Gates Foundation effective as of November 11, 2024, as amended to date

Subaward Agreement between the Consortium Management Firm, National Collegiate Inventor s and Innovators Alliance, Inc.

d/b/a/ VentureWell and Daré Bioscience, I nc ., effective as of October 12, 2024

03/31/2025 10.12

10.12+ Subaward Agreement between the Consortium Management Firm, National Collegiate Inventors and Innovators Alliance, Inc.

d/b/a/ VentureWell and Daré Bioscience, Inc., effective as of October 12, 2024

03/31/2025 10.13

10.13 Royalty Interest Financing Agreement entered into as of December 21, 2023 between Dare Bioscience, Inc.

14 unchanged sentences

MANAGEMENT CONTRACTS AND COMPENSATORY PLANS

Daré Bioscience, Inc.

10.18(a)* Daré Bioscience, Inc.

Amended and Restated 2014 Stock Incentive Plan

8-K 001-36395 7/12/2018 10.1

Form of Incentive Stock Option Agreement for grants under the Daré Bioscience, Inc.

10.18(b)* Form of Incentive Stock Option Agreement for grants under the Daré Bioscience, Inc.

Amended and Restated 2014 Stock Incentive Plan

10-Q 001-36395 8/13/2018 10.3

Form of Nonstatutory Stock Option Agreement for grants under the Daré Bioscience, Inc.

10.18(c)* Form of Nonstatutory Stock Option Agreement for grants under the Daré Bioscience, Inc.

Amended and Restated 2014 Stock Incentive Plan

10-Q 001-36395 8/13/2018 10.4

2014 Employee Stock Purchase Plan

S-1/A 333-194442 3/31/2014 10.26

Daré Bioscience, Inc.

10.19(a)* Daré Bioscience, Inc.

2022 Stock Incentive Plan

001-36395 8/12/2024 10.7

Form of Incentive Stock Option Agreement for Grants under the Daré Bioscience, Inc.

10.19(b)* Amendment No.

1 to Daré Bioscience, Inc.

2022 Stock Incentive Plan

8-K 001-36395 7/9/2025 10.1

10.19(c)* Form of Incentive Stock Option Agreement for Grants under the Daré Bioscience, Inc.

2022 Stock Incentive Plan

8-K 001-36395 6/24/2022 10.1(b)

Form of Nonstatutory Stock Option Agreement for Grants under the Daré Bioscience, Inc.

10.19(c)* Form of Nonstatutory Stock Option Agreement for Grants under the Daré Bioscience, Inc.

2022 Stock Incentive Plan

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S-1 333-194442 03/10/2014 10.16

10.18* Amended and Restated Non-Employee Director Compensation Policy (as amended on April 2024)

10.22* Amended and Restated Non-Employee Director Compensation Policy (as amended through January 28, 2025)

10-Q 001-36395 05/13/2025 10.10

6 unchanged sentences

10-Q 001-36395 05/14/2020 10.13(b)

Amendment No.

10.23(c)* Amendment No.

2 to Employment Agreement between Daré Bioscience, Inc.

1 unchanged sentence

08/12/2024 10.5

10.20(a)* Employment Agreement by and between Daré Bioscience, Inc.

and Lisa Walters-Hoffert dated as of August 15, 2017

8-K 001-36395 08/18/2017 10.2

10.20(b)* Amendment No.

1 to Employment Agreement between Daré Bioscience, Inc.

and Lisa Walters-Hoffert dated as of March 9, 2020

10-Q 001-36395 05/14/2020 10.14(b)

10.24* Daré Bioscience, Inc.

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19.1 Daré Bioscience, Inc.

Amended and Restated I nsider Trading Policy (October 22, 2024)

Amended and Restated Insider Trading Policy (October 22, 2024)

10-K 001-36395 03/31/2025 19.1

21.1 Subsidiaries of the registrant

23.1 Consent of Haskell & White LLP

23.2 C onsent of Haskell & White LLP

31.1 Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended

3 unchanged sentences

Policy on Recovery of Erroneously Awarded Compensation

10-K 001-36395 03/28/2024 99.7

101.INS XBRL Instance Document X

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (Continued)

Critical Audit Matter – Estimating the Allocation of Transaction Price in Other Income Recognition

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that:

(1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Description of the Critical Audit Matter

During the year ended December 31, 2024, the Company entered into a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (US) LLC (“XOMA”).

The Company received $22.0 million from XOMA in connection with entering into the royalty purchase agreements, which was determined as the transaction price.

As described in Note 2 to the consolidated financial statements, the Company recognized other income in accordance with the principles outlined in ASC 610-20, Other Income – Gains and Losses from the Derecognition of Nonfinancial Assets, which requires the allocation of the transaction price to each performance obligation based on their relative standalone selling prices.

The observable standalone selling prices were not available, and therefore the Company estimated these prices using the adjusted market assessment approach.

This fair value approach requires management to make significant estimates and judgments, including the timing and amounts of projected net sales, probabilities of success in product development and regulatory approvals, and appropriate discount and royalty rates.

Estimating probabilities of success for early-stage assets is inherently uncertain.

We identified the estimation of the allocation of the transaction price to multiple performance obligations in the Company’s contract with XOMA as a critical audit matter due to the complexity involved in determining the standalone selling price of each performance obligation, which directly affects the amount of other income recognized in each period.

This in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures to evaluate the reasonableness of management’s significant estimates and assumptions, several of which extend many years into the future.

How the Critical Audit Matter Was Addressed in the Audit

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

We obtained an understanding of the marketing status of the underlying commercialized product and an understanding of the development status and development plan for the two underlying product candidates, which included estimated timelines and milestones.

We evaluated management’s development of the market assessment approach, which includes the identification of key inputs and assumptions to the fair value model.

We evaluated the sufficiency and appropriateness of the audit evidence supporting key inputs and assumptions to the fair value model.

We also evaluated the appropriateness of the discount rate used by management in the fair value model and evaluated the expected future royalty rates.

We performed independent mathematical accuracy tests of the Company’s fair value model.

We also performed substantive testing by recalculating the allocated transaction price using alternative assumptions, comparing the results to the Company’s estimates, and assessing whether the other income recognized was consistent with the performance obligations completed during the period.

Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

/s/ Haskell & White LLP

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Cash and cash equivalents $ 24,711,356 $ 15,698,174

Other receivables 229,982 949,211

Prepaid expenses 2,519,707 6,118,272

Prepaid expenses and other current assets 2,352,523 2,749,689

Total current assets 27,063,879 18,447,863

Property and equipment, net 1,558,890 1,335,732

Deposits 12,027 1,163,477

Operating lease right-of-use assets 1,097,580 1,206,942

Finance lease right-of-use assets 1,744,775 —

Other non-current assets 1,009,439 1,110,594

Total assets $ 32,474,563 $ 22,101,131

Liabilities and stockholders’ deficit

Liabilities and stockholders’ equity (deficit)

Current Liabilities

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Deferred grant funding 19,651,452 16,561,625

Current portion of lease liabilities 548,638 468,726

Current portion of liability related to sale of future royalties 11,711 4,054

Current portion of lease liabilities (operating) 602,552 548,638

Current portion of lease liabilities (finance) 1,494,102 —

Total current liabilities 23,685,687 21,613,067

1 unchanged sentence

Liability related to the sale of future royalties, net 5,386,877 4,745,770

Lease liabilities, non-current 754,383 935,743

Lease liabilities long term (operating) 559,365 754,383

Total liabilities 29,631,929 28,113,220

Commitments and contingencies (Note 14)

Stockholders' deficit

Stockholders' equity (deficit)

Preferred stock, $ 0.01 par value, 5,000,000 shares authorized

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Accumulated deficit ( 188,688,904 ) ( 175,289,630 )

Total stockholders' deficit ( 6,012,089 ) ( 5,047,640 )

Total liabilities and stockholders' deficit $ 22,101,131 $ 21,282,215

See accompanying notes.

Total stockholders' equity (deficit) 2,842,634 ( 6,012,089 )

Total liabilities and stockholders' equity (deficit) $ 32,474,563 $ 22,101,131

See accompanying notes to the consolidated financial statements.

Daré Bioscience, Inc.

2 unchanged sentences

Years Ended December 31,

License fee revenue $ — $ 1,000,000

Milestone revenue — 1,800,000

Royalty revenue 9,784 7,885

License fee revenue and other revenue $ 1,030,193 $ 9,784

Total revenue 1,030,193 9,784

Cost of revenues 295,799 —

Operating expenses

General and administrative 9,156,061 12,109,691

Selling, general and administrative 8,763,376 9,156,061

Research and development 5,523,352 14,305,208

License fee expense 100,000 100,000

Total operating expenses 14,286,728 23,461,269

2 unchanged sentences

Sale of royalty and milestone rights, net of transaction costs (Note 13) — 20,379,376

Other (expense) income ( 981,490 ) 778,489

Other income (expense) 153,060 ( 981,490 )

Net loss $ ( 13,399,274 ) $ ( 4,053,599 )

5 unchanged sentences

Basic and diluted 11,178,752 8,497,459

See accompanying notes.

See accompanying notes to the consolidated financial statements.

Daré Bioscience, Inc.

6 unchanged sentences

Stock-based compensation — — 2,203,257 — — 2,203,257

Issuance of common stock from the exercise of warrants

112,793 11 1,299,365 — — 1,299,376

Issuance cost on equity line paid in common stock 137,614 14 500,213 — — 500,227

Issuance of common stock, net of issuance costs 109,655 11 453,568 — — 453,579

1,149,578 115 9,346,541 — — 9,346,656

Issuance of common stock warrants, net of issuance costs

— — 834,510 — — 834,510

Reverse stock split adjustment 121,956 12 ( 12 ) — — —

Net loss — — — — ( 4,053,599 ) ( 4,053,599 )

2 unchanged sentences

Stock-based compensation — — 1,496,562 — — 1,496,562

Issuance cost on equity line paid in common stock

137,614 14 500,213 — — 500,227

Issuance of common stock, net of issuance costs 5,799,116 580 20,749,669 — — 20,750,249

Reverse stock split adjustment

121,956 12 ( 12 ) —

Net loss — — — — ( 13,399,274 ) ( 13,399,274 )

1 unchanged sentence

Balance at December 31, 2025 14,499,502 $ 1,450 $ 191,951,711 $ ( 421,623 ) $ ( 188,688,904 ) $ 2,842,634

See accompanying notes.

See accompanying notes to the consolidated financial statements.

Daré Bioscience, Inc.

4 unchanged sentences

Net loss $ ( 13,399,274 ) $ ( 4,053,599 )

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

Depreciation expense 42,325 38,363

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

Depreciation and amortization

1,634,486 42,325

Right-of-use asset - operating lease

3 unchanged sentences

Non-cash royalty revenue related to sale of future royalties ( 6,298 ) 202

Non-cash interest expense on liability related to sale of future royalties 317,318 24,289

Non-cash interest expense

82,502 317,318

Changes in operating assets and liabilities:

Accounts receivable

Other receivables ( 331,026 ) 719,229

Prepaid expenses 668,486 3,598,565

402,414 ( 1,152,974 )

Other current assets ( 65,405 ) —

Other non-current assets ( 78,723 ) 45,562

4 unchanged sentences

Interest payable

572,561 520,816

Deferred grant funding 3,089,828 2,824,471

Net cash provided by (used in) operating activities

Deferred revenue

( 1,000,000 ) —

Net cash (used in) provided by operating activities

( 9,885,870 ) 5,473,555

Cash flows from investing activities

3 unchanged sentences

Net proceeds from issuance of common stock 20,930,126 453,579

Proceeds from the exercise of common stock warrants — 1,299,376

Proceeds from the sale of future royalties, net

Payments of deferred offering costs ( 321,686 ) ( 79,308 )

Repayment of liability on sale of future royalties

Issuance of note payable

486,721 561,663

Payments on note payable

( 553,829 ) ( 579,223 )

Principal payments on finance lease ( 1,264,188 ) —

Net cash provided by financing activities 19,277,144 354,522

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Supplemental disclosure of non-cash investing and financing activities:

Operating right-of-use assets obtained in exchange for new operating lease liabilities $ 358,315 $ 1,291,425

Remeasurement of operating lease right-of-use assets and lease liabilities due to lease modification $ 407,534 $ 358,315

Finance right-of-use assets obtained in exchange for new finance lease liabilities $ 2,841,027 $ —

Remeasurement of finance lease right-of-use assets and lease liabilities due to lease modification $ 82,736 $ —

Prepaid rent reclassified to finance lease right-of-use asset $ 458,850 $ —

Deferred issuance costs applied from prepayments made in the prior year $ 179,877 $ —

Issuance cost on equity paid in common stock $ — $ 500,227

Additions to property and equipment and reduction of deposits $ — $ 749,036

Issuance cost recorded under additional-paid-in-capital $ — $ 834,510

See accompanying notes.

See accompanying notes to the consolidated financial statements.

Daré Bioscience, Inc.

3 unchanged sentences

Daré Bioscience, Inc.

is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority.

is a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real solutions.

Daré Bioscience, Inc.

and its wholly-owned subsidiaries operate one segment.

and its wholly-owned subsidiaries operate in one segment.

In this report, the “Company” refers collectively to Daré Bioscience, Inc.

2 unchanged sentences

The Company's programs target unmet needs in women's health, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause, and aim to enhance outcomes and convenience.

The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, research and development activities to advance its product candidates through clinical development and regulatory approval.

The Company's portfolio of product candidates includes drug and drug/device product candidates and potential product candidates in various stages of development.

The first U.S.

Food and Drug Administration (FDA)-approved product to emerge from the Company's portfolio is XACIATO™ (clindamycin phosphate) vaginal gel 2%, or XACIATO.

In March 2022, the Company entered into an exclusive global license agreement with an affiliate of Organon & Co., Organon International GmbH, or Organon, to commercialize XACIATO.

Under the license agreement, Organon (and/or its affiliates, agents or sublicensees) is solely responsible for the marketing, distribution and sale of XACIATO in the United States (and outside the U.S.

if approved in non-U.S.

jurisdictions in the future).

In January 2024, Organon announced that XACIATO was available across the U.S.

As described below, to provide funding for the development of the product candidates in the Company's pipeline, in April 2024, the Company entered into an agreement with XOMA (US) LLC (“XOMA”) whereby the Company sold its rights to all royalty and potential milestone payments based on net sales of XACIATO under its agreement with Organon, net of the Company's obligations to certain third parties, until XOMA receives a specified return on its investment, after which the Company will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon.

The Company’s operations have historically focused on research and development activities to advance its product candidates through clinical development and regulatory approval .

While research and development remain an important part of the Company's strategy, the Company announced in March 2025 an expansion of its business model to include a dual-path approach to bringing new products to market.

For select proprietary formulations, the Company is pursuing both traditional FDA approval and earlier market access via outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), which may compound and distribute certain drugs without patient-specific prescriptions.

This dual-path approach reflects a shift in the Company’s operational priorities and resource allocation toward commercial execution, including partnerships and product distribution via Section 503B outsourcing facilities and select consumer health channels.

The Company uses the term "Section 503B compounding" to refer to the production and supply of compounded drugs by outsourcing facilities registered under Section 503B of the FDCA without patient-specific prescriptions in accordance with Section 503B of the FDCA.

In addition to prescription-based offerings — both products approved by the U.S.

Food and Drug Administration (FDA) and compounded drugs— the Company intends to bring to market select consumer health products that do not require a physician’s prescription.

The Company's portfolio of product candidates includes drug and drug/device product candidates and potential product candidates in various stages of development, from preclinical through a Phase 3 clinical study, and will require review and approval from the FDA or a comparable foreign regulatory authority, prior to being marketed and sold.

The first FDA-approved product to emerge from the Company's portfolio is XACIATO® (clindamycin phosphate) vaginal gel 2%, or XACIATO.

In 2022, the Company licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO to an affiliate of Organon & Co., Organon International GmbH, or Organon.

In January 2024, Organon announced that XACIATO was available nationwide in the U.S.

In April 2024, the Company sold its rights to all royalty and potential milestone payments based on net sales of XACIATO under its agreement with Organon, net of its obligations to certain third parties, to XOMA (US) LLC, or XOMA, until XOMA receives a specified return on its investment, after which the Company will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon.

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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GAAP, as defined by the Financial Accounting Standards Board, or FASB.

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S.

These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries.

One wholly-owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia.

The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency.

The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss.

All intercompany transactions and accounts have been eliminated in consolidation.

Use of Estimates

The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period.

Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, management's judgments with respect to its revenue arrangements, liability related to the sale of future royalties, valuation of stock-based awards and the accrual of research and development expenses.

Estimates are periodically reviewed in light of changes in circumstances, facts and experience.

Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results.

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation.

These reclassifications had no effect on the reported results of operations.

Going Concern

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The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern.

At December 31, 2024, the Company had an accumulated deficit of approximately $ 175.3 million, unrestricted cash and cash equivalents of approximately $ 15.7 million, and a working capital deficit of approximately $ 3.2 million.

The Company's unrestricted cash and cash equivalents at December 31, 2024 represented funds received under grant agreements that generally may be applied solely toward direct costs for carrying out the respective projects under those grant agreements.

At December 31, 2025, the Company had cash and cash equivalents of approximately $ 24.7 million and working capital of approximately $ 3.4 million.

The Company's cash and cash equivalents at December 31, 2025 includes funds received under grant agreements that may be applied solely toward direct costs for the funded projects under those grant agreements, other than an approximately 5 % to 22 % indirect cost allowance, and as of December 31, 2025, the Company's deferred grant funding liability was approximately $ 19.7 million.

See Note 15 Grant Awards.

For the year ended December 31, 2024, the Company incurred a net loss of $ 4.1 million and had positive cash flow from operations of approximately $ 5.4 million.

The Company's net loss and cash flow from operations for the year ended December 31, 2024 were positively impacted

by the approximately $ 20.4 million of net proceeds the Company received from the sale in April 2024 of its rights to future royalty and milestone payments and revenue.

See below and Note 13, Royalty Purchase Agreements.

Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying consolidated financial statements.

The Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current strategy.

There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders.

If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock.

The Company's consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

The Company will require additional capital to advance the development programs in its pipeline that are not currently being supported by non-dilutive grant or other funding, to enable further investment across its entire portfolio of product candidates, and to support its operating plans.

The Company is currently seeking to raise capital under its Regulation A offering (see Note 17 Subsequent Events) and will continue to evaluate and may pursue various other capital raising options, including sales of equity, debt financings, government or other grant funding, collaborations, structured financings, and commercial collaborations or other strategic transactions.

The Company’s ability to obtain additional capital, including through its ongoing Regulation A offering, and the timing and terms thereof, depend on various factors, many aspects of which are not entirely within its control, and there can be no assurance that capital will be available when needed or, if available, on terms favorable to the Company and its stockholders.

Raising additional capital may cause substantial dilution to the Company’s stockholders, restrict its operations or require it to relinquish rights in its technologies or product candidates and their future revenue streams.

If the Company cannot raise capital when needed, on favorable terms or at all, the Company will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its product candidate programs and/or reduce expenses.

The Company has a history of losses from operations, net losses and negative cash flows from operations.

At December 31, 2025, the Company had an accumulated deficit of approximately $ 188.7 million and the Company incurred a net loss of approximately $ 13.4 million and had negative cash flow from operations of approximately $ 9.9 million for the year ended December 31, 2025.

Because the Company is in the early stages of executing against its Section 503B compounding and consumer health products business strategies and, as an organization, the Company has no experience in or infrastructure for commercializing products, both the timing and amount of potential revenue the Company may generate remain uncertain.

As a result, the Company may continue to incur significant losses from operations and negative cash flows from operations for the next several years, and may never generate sufficient revenues to finance its operations or achieve profitability.

Based on the Company’s current analysis of the conditions described above, there is substantial doubt about the Company's ability to continue as a going concern within the 12

month period from the issuance date of the accompanying consolidated financial statements.

The accompanying consolidated financial statements were prepared on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business.

The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of our ability to remain a going concern.

Segment Information

Operating segments are defined as components of an enterprise about which discrete financial information is available for evaluation the Chief Operating Decision Maker, or CODM, or decision-making group in making decisions on how to allocate resources and assess performance.

Operating segments are defined as components of an enterprise about which discrete financial information is available for evaluation by the Chief Operating Decision Maker, or CODM, or decision-making group in making decisions on how to allocate resources and assess performance.

The Company's CODM is the Chief Executive Officer, or CEO.

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In addition, proportionate adjustments were made in accordance with the applicable terms of outstanding stock options and warrants, the Company’s stock incentive plans and an existing agreement to the (a) per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, (b) number of shares available for the grant of awards under the Company’s stock incentive plans, and (c) per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock and warrants potentially issuable by the Company in its sole discretion pursuant to an existing agreement.

Cash, Cash Equivalents and Restricted Cash

The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents.

The Company has an aggregate of approximately $ 0.3 million in restricted cash as of December 31, 2024 and 2023 related to (i) letters of credit established under real property leases for the Company's wholly-owned subsidiary, Dare MB Inc., that serve as security for potential future default of lease payments, and (ii) collateralized cash for the Company's credit cards.

The restricted cash is unavailable for withdrawal or for general obligations and is included in other non-current assets on the Company's consolidated balance sheets.

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S.

These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries.

One wholly-owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia.

The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency.

The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is

reported in Accumulated Other Comprehensive Loss.

All intercompany transactions and accounts have been eliminated in consolidation.

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation.

These reclassifications had no effect on the reported results of operations.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation.

Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally five years .

Repair and maintenance costs are charged to expense as incurred.

Impairment of Long-Lived Assets

Long-lived assets consist primarily of property and equipment and right-of-use assets.

The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.

Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the asset or asset group are expected to generate, including its eventual residual value.

If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds its fair value.

The Company did not recognize any impairment losses for either of the years ended December 31, 2024 or 2023.

The Company recorded a loss on the disposal of a fixed asset of $ 0.6 million for the year ended December 31, 2024.

No such losses were recorded during the year ended December 31, 2023.

Grant Funding

The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Gates Foundation, or the Foundation.

Under the Foundation grant, which the Company considers to be a research and development contract under FASB Accounting Standards Codification, or ASC, Topic 730 Research and Development , the Company granted the Foundation a Humanitarian License which gives the Foundation the right to make the funded developments accessible at an affordable price to people within developing countries.

Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to International Accounting Standards 20, Accounting for Grants and Disclosure of Government Assistance , or IAS 20.

Under IAS 20, the Company recognizes grant funding in the statements of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period.

The Company adopted this policy in 2018.

For the years ended December 31, 2024 and December 31, 2023, the Company recognized approximately $ 8.8 million and $ 9.3 million, respectively, in the statements of operations as a reduction to research and development expense.

Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant funding liability in the Company's consolidated balance sheets.

Use of Estimates

The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period.

Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, management's judgments with respect to its revenue arrangement, liability related to the sale of future royalties, valuation of stock-based awards and the accrual of research and development expenses.

Estimates are periodically reviewed in light of changes in circumstances, facts and experience.

Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results.

Sale of Future Payments

On April 29, 2024, the Company entered into and closed a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA pursuant to which the Company sold its right, title and interest in the following to XOMA (i) all future net royalty and potential net milestone payments the Company would otherwise receive from Organon based on net sales of XACIATO, (ii) a portion of future net sales of Ovaprene and a portion of a potential future milestone payment the Company may receive under its license agreement with Bayer related to

Ovaprene, and (iii) a portion of future net sales of Sildenafil Cream.

The Company received $ 22.0 million from XOMA in connection with entering into the royalty purchase agreements.

Under the terms of the royalty purchase agreements, if XOMA receives total payments under the royalty purchase agreements equal to an amount that exceeds $ 88.0 million, XOMA will pay $ 11.0 million to the Company for each successive $ 22.0 million XOMA receives under the royalty purchase agreements.

If the Company earns any such payments, they will be accounted for as variable consideration under ASC 606, Revenue Recognition, and will be recorded as income when such payments are received.

See Note 13, Royalty Purchase Agreements, for additional information regarding the terms of the royalty purchase agreements.

The Company evaluated the expected cash flows to XOMA from royalties and milestone payments expected to be earned on XACIATO, Ovaprene and Sildenafil Cream over the period that the Company expects it will take for XOMA to receive total payments of $ 88.0 million under the royalty purchase agreements, and determined to allocate the $ 22.0 million it received from XOMA in connection with entering into the royalty purchase agreements, net of transaction costs of approximately $ 1.6 million, to the traditional royalty purchase agreement for XACIATO, and none of it to the synthetic royalty purchase agreement for Ovaprene and Sildenafil Cream.

The cash flows to XOMA from royalties and milestone payments expected to be earned on Ovaprene and Sildenafil Cream are expected to be de minimis over the period that the Company expects it will take for XOMA to receive total payments of $ 88.0 million under the royalty purchase agreements because, unlike XACIATO, Ovaprene and Sildenafil Cream are still in development stage and not commercial assets.

The Company determined that the traditional royalty purchase agreement represents a complete sale of a nonfinancial asset (the Company's right, title and interest in and to future payments related to commercial sales of XACIATO) for which XOMA bears all benefit and for which the Company has no obligations or involvement going forward, and therefore should be accounted for within the scope of ASC 610-20, Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets .

The $ 22.0 million net of transaction costs of approximately $ 1.6 million, was recorded as other income on the Company's consolidated statements of operations and comprehensive loss.

Liability Related to the Sale of Future Royalties

In December 2023, the Company entered into a royalty interest financing agreement with United in Endeavor, or United, pursuant to which the Company sold to United an interest in royalty and milestone payments the Company receives based on net sales of XACIATO.

The Company received $ 5.0 million from United in connection with entering into the royalty interest financing agreement.

The Company evaluated the terms of the royalty interest financing agreement and concluded that its features were similar to those of a debt instrument.

The Company recognized the $ 5.0 million it received as a liability on its consolidated balance sheet because the Company agreed to make payments to United until such time that United has received aggregate payments equaling a 12 % internal rate of return on the $ 5.0 million.

Interest expense for the liability related to the sale of future royalties is recognized using the effective interest rate method over the expected term of the royalty interest financing agreement.

The liability related to the sale of future royalties and related interest expense are based on current estimates of future royalties, which estimates are based on forecasts of XACIATO net sales.

The Company periodically assesses the forecasted net sales and to the extent the amount or timing of estimated royalty payments are materially different than previous estimates, the Company will account for any such change by adjusting the liability related to the sale of future royalties and prospectively recognizing the related non-cash interest expense.

In connection with the royalty investment financing agreement the Company entered into, the Company issued a warrant to purchase up to an aggregate of 5.0 million shares of the Company's common stock.

The warrant was allocated a relative fair value of approximately $ 0.8 million using a Black-Scholes option pricing model.

The $ 0.8 million relative fair value of the warrant was recorded as a debt discount with an offset to additional paid in capital on the Company's 2023 consolidated balance sheets as the warrants were deemed to be equity classified.

Risks and Uncertainties

The Company will require approvals from the FDA, or foreign regulatory agencies prior to being able to sell any products.

The Company received approval from the FDA for XACIATO in December 2021.

There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals.

If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and financial position.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully

commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology.

As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

Concentration of Credit Risk

The Company maintains cash balances at various financial institutions and such balances commonly exceed the $ 250,000 amount insured by the Federal Deposit Insurance Corporation.

The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S.

The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents.

Fair Value of Financial Instruments

GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available.

The three-level hierarchy of valuation techniques established to measure fair value is defined as follows:

inputs are unadjusted quoted prices in active markets for identical assets or liabilities.

inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities.

unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of December 31, 2024 and December 31, 2023.

There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of December 31, 2024 or December 31, 2023.

Fair Value Measurements

Level 1 Level 2 Level 3 Total

Balance at December 31, 2024

Current assets:

Cash equivalents (1)

$ 15,283,784 $ — $ — $ 15,283,784

Balance at December 31, 2023

Current assets:

Cash equivalents (1)

$ 9,982,079 $ — $ — $ 9,982,079

(1) Represents cash held in money market funds.

Recently Adopted Accounting Pronouncements

In November 2023, the FASB issued Accounting Standard Update, or ASU, 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, or ASU 2023-07, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.

Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.

The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024.

The Company adopted ASU 2023-07 on December 31, 2024, which adoption only impacted the Company's segment reporting disclosures.

See Note 16, Segment Information, for disclosures related to the adoption of ASU 2023-07.

Recently Issued Accounting Pronouncements

In November 2024, the FASB issued ASU 2024-3, Disaggregation of Income Statement Expenses.

ASU 2024-3 requires new financial statement disclosures in tabular format, disaggregating information about prescribed categories underlying any relevant income statement expense captions.

Additionally, in January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03.

The standard provides guidance to expand disclosures related to the disaggregation of income statement expenses.

The standard requires, in the notes to the financial statements, disclosure of specified information about certain costs and expenses, which includes purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption.

This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027, on a retrospective or prospective basis, with early adoption permitted.

The Company is assessing the guidance, noting the adoption impacts disclosure only.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures, which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.

In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid.

ASU 2023-09 will be effective for annual periods beginning January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively.

The Company is evaluating the disclosure impact of ASU 2023-09 on its consolidated financial statements.

The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements.

Significant Accounting Policies

Revenue Recognition

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The Company enters into collaboration and licensing agreements under which it out-licenses certain rights to its products or product candidates to third parties.

The terms of these arrangements typically include payment of one or more of the following to the Company:

The terms of these arrangements typically

include payment of one or more of the following to the Company:

non-refundable, up-front license fees;

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The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

To date, the Company has recognized $ 11.0 million in license fee revenue, $ 10.0 million of which represents the upfront payment under its license agreement for XACIATO and $ 1.0 million of which represents the payment required by the first amendment to such license agreement entered into in July 2023.

To date, the Company has recognized $ 12.0 million in license fee revenue, $ 10.0 million of which represents the upfront payment under its license agreement for XACIATO, $ 1.0 million of which represents the payment required by the first amendment to such license agreement entered into in July 2023, and $ 1.0 million of which represents the license fee revenue recognized upon the termination of a license agreement in December 2025 (see Bayer License, below).

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

To date, the Company has recognized approximately $ 26,000 in royalty revenue.

Product Supply.

Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options.

The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations.

The Company evaluates whether it is the principal or agent in the arrangement.

The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer.

Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent.

To date, the Company has recognized approximately $ 205,000 in revenue along with $ 201,000 in other expense attributed to the cost of revenue associated with its product supply arrangement for XACIATO, which is recorded in other income in the Company's 2023 consolidated statement of operations and comprehensive loss.

That arrangement was terminated effective December 14, 2023 and the Company will not recognize product supply revenue associated with that agreement in the future.

Bayer License .

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and received a $ 1.0 million upfront non-refundable license fee payment from Bayer (See Note 3, Strategic Agreements).

The $ 1.0 million upfront payment is recorded as deferred license revenue in the Company's consolidated balance sheets at December 31, 2024 and 2023.

Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $ 20.0 million.

The $ 1.0 million upfront payment was recorded as deferred license revenue in the Company's consolidated balance sheets at December 31, 2024.

Bayer, in its sole discretion, had the right to make the license effective by paying the Company an additional $ 20.0 million.

The Company concluded that there was one significant performance obligation related to the $ 1.0 million upfront payment:

a distinct license to commercialize Ovaprene effective upon the receipt of the $ 20.0 million fee.

The $ 1.0 million upfront payment will be recorded as license revenue at the earlier of (i) the point in time the Company receives the $ 20.0 million fee, the license is transferred to Bayer and Bayer is able to use and benefit from the license and (ii) the termination of the agreement.

To date, neither of the foregoing has occurred.

Under its license agreement with Bayer, the Company will also be entitled to receive (a) milestone payments totaling up to $ 310.0 million related to the commercial sales of Ovaprene, if all such milestones are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue.

In November 2025, the Company received notice from Bayer that it was terminating the license agreement.

The Company and Bayer mutually agreed to terminate the agreement effective as of December 2, 2025 and the $ 1.0 million upfront payment was recognized as license fee revenue on such date.

Milestone Payments.

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Potential future milestone payments not within the Company's control, such as where achievement of the specified milestone depends on activities of a third party or regulatory approval, are not considered probable of being achieved until the specified milestone occurs.

As of December 31, 2024, the Company has recognized $ 1.8 million of milestone payment revenues.

Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place.

Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal of revenue will not take place.

Potential future royalty payments will be recorded as revenue when the associated sales occur (See Note 3, Strategic Agreements).

The Company determines if an arrangement is a lease at inception.

Operating leases are included in other non-current assets as right-of-use, or ROU, lease assets, current portion of lease liabilities, and long-term lease liabilities on the Company's consolidated balance sheets.

ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease.

Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term.

If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.

The ROU lease asset also includes any lease payments made and excludes lease incentives.

The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option.

Lease expense for lease payments is recognized on a straight-line basis over the lease term (See Note 11, Leased Properties).

Research and Development Costs

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses.

Research and development costs are expensed as incurred.

Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed.

Australian Research and Development Tax Incentive Program

The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to receive a cash refund from the Australian Taxation Office for eligible research and development expenditures.

The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to receive a cash refund from the Australian Taxation Office for eligible research and development

expenditures.

To be eligible, the Company must have revenue of less than AUD $ 20.0 million during the reimbursable period and cannot be controlled by income tax exempt entities.

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The Company classifies its estimate for the Tax Incentive as other current assets on its consolidated balance sheets.

For the years ended December 31, 2024 and 2023, the Company recognized approximately $ 46,000 and approximately $ 0.6 million, respectively, as a reduction to research and development expense for expenses incurred that it believes are eligible for the Tax Incentive.

At December 31, 2024 and 2023, the Company recorded a receivable for the estimated Tax Incentive of approximately $ 46,000 and $ 0.6 million, respectively, in other receivables on the accompanying consolidated balance sheets.

Research and Development Costs

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses.

Research and development costs are expensed as incurred.

Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed.

The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statements of operations.

Net Loss Per Share

Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents.

Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive.

There were stock options exercisable into 883,334 and 788,569 shares of common stock outstanding at December 31, 2024 and 2023, respectively.

There were warrants exercisable into 1,268,572 shares of common stock outstanding at each of the years ended December 31, 2024 and 2023.

These securities were not included in the

computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years.

For the years ended December 31, 2025 and 2024, the Company did not incur any research and development expenses that it believes are eligible for the Tax Incentive.

Grant Funding

The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Gates Foundation, or the Foundation.

Under the Foundation grant, which the Company considers to be a research and development contract under FASB Accounting Standards Codification, or ASC, Topic 730 Research and Development , the Company granted the Foundation a Humanitarian License which gives the Foundation the right to make the funded developments accessible at an affordable price to people within developing countries.

Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to International Accounting Standards 20, Accounting for Grants and Disclosure of Government Assistance , or IAS 20.

Under IAS 20, the Company recognizes grant funding in the statements of operations and comprehensive loss as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period.

The Company adopted this policy in 2018.

For the years ended December 31, 2025 and December 31, 2024, the Company recognized approximately $ 16.4 million and $ 8.8 million, respectively, in the statements of operations and comprehensive loss as a reduction to research and development expense.

Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant funding liability in the Company's consolidated balance sheets.

Stock-Based Compensation

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Compensation expense is recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the requisite service period of the award.

The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, the volatility of the Company's common stock, risk free interest rate, and dividend yield.

Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards.

Forfeitures are accounted for in the period they occur.

The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as the fair value of the Company's common stock, which is measured as the closing price of the Company's common stock on the date of the grant, the expected term, the volatility of the Company's common stock, risk free interest rate, and dividend yield.

Due to the limited number of option exercises, the simplified method was utilized in order to determine the expected term of the awards.

The Company compared U.S.

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Management evaluated the Company’s tax positions and, as of December 31, 2025 and 2024, the Company had approximately $ 3.1 million and $ 2.9 million of unrecognized benefits, respectively.

The tax years 2021 to 2023 and 2020 to 2023 remain open to examination by federal and state taxing authorities, respectively, while the statute of limitations for U.S.

The tax years 2022 to 2024 and 2021 to 2024 remain open to

examination by federal and state taxing authorities, respectively, while the statute of limitations for U.S.

net operating losses generated remain open beginning in the year of utilization.

The Company is not currently under examination.

Fair Value of Financial Instruments

GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available.

The three-level hierarchy of valuation techniques established to measure fair value is defined as follows:

inputs are unadjusted quoted prices in active markets for identical assets or liabilities.

inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities.

unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of December 31, 2025 and December 31, 2024.

There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of December 31, 2025 or December 31, 2024.

Fair Value Measurements

Level 1 Level 2 Level 3 Total

Balance at December 31, 2025

Current assets:

Cash equivalents (1)

$ 24,356,333 $ — $ — $ 24,356,333

Balance at December 31, 2024

Current assets:

Cash equivalents (1)

$ 15,283,784 $ — $ — $ 15,283,784

(1) Represents cash held in money market funds.

The carrying amounts of all prepaid expenses and other current assets, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments.

In addition, the carrying value of the liability related to the sale of future royalties approximates its fair value as of December 31, 2025, and is based on the Company’s current estimate of future royalties expected to be earned over the estimated life of the royalty interest financing arrangement.

See Note 12 for the description of the Level 3 inputs used to estimate the carrying value of the liability.

C ash, Cash Equivalents and Restricted Cash

The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents.

The Company has an aggregate of approximately $ 0.3 million in restricted cash as of December 31, 2025 and 2024 related to (i) letters of credit established under real property leases for the Company's wholly-owned subsidiary, Dare MB Inc., that serve as security for potential future default of lease payments, and (ii) collateralized cash for the Company's credit cards.

The restricted cash is unavailable for withdrawal or for general obligations and is included in other non-current assets on the Company's consolidated balance sheets.

Concentration of Credit Risk

The Company maintains cash balances at various financial institutions and such balances commonly exceed the $ 250,000 amount insured by the Federal Deposit Insurance Corporation.

The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S.

The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents.

The Company performs an assessment of warrants upon issuance to determine their proper classification in the financial statements based upon the warrant’s specific terms, in accordance with the authoritative guidance provided in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”).

The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480 and whether the warrants meet all of the requirements for equity classification under ASC 815-40, including whether the warrants are indexed in the Company’s own Common Stock and whether the warrant holders could potentially require cash settlement of the warrants.

For issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital.

For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter.

Sale of Future Payments

On April 29, 2024, the Company entered into and closed a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA pursuant to which the Company sold its right, title and interest in the following to XOMA (i) all future net royalty and potential net milestone payments the Company would otherwise receive from Organon based on net sales of XACIATO, (ii) a portion of future net sales of Ovaprene and a portion of the $ 20.0 million payment that the Company could have potentially received under its since terminated license agreement with Bayer relating to Ovaprene, and (iii) a portion of future net sales of Sildenafil Cream.

The Company received $ 22.0 million from XOMA in connection with entering into the royalty purchase agreements.

Under the terms of the royalty purchase agreements, if XOMA receives total payments under the royalty purchase agreements equal to an amount that exceeds $ 88.0 million, XOMA will pay $ 11.0 million to the Company for each successive $ 22.0 million XOMA receives under the royalty purchase agreements.

If the Company earns any such payments, they will be accounted for as variable consideration under ASC 606, Revenue Recognition, and will be recorded as income when such payments are received.

See Note 13, Royalty Purchase Agreements, for additional information regarding the terms of the royalty purchase agreements.

The Company evaluated the expected cash flows to XOMA from royalties and milestone payments expected to be earned on XACIATO, Ovaprene and Sildenafil Cream over the period that the Company expected it would take for XOMA to receive total payments of $ 88.0 million under the royalty purchase agreements, and determined to allocate the $ 22.0 million it received from XOMA in connection with entering into the royalty purchase agreements, net of transaction costs of approximately $ 1.6 million, to the traditional royalty purchase agreement for XACIATO, and none of it to the synthetic royalty purchase agreement for Ovaprene and Sildenafil Cream.

The cash flows to XOMA from royalties and milestone payments expected to be earned on Ovaprene and Sildenafil Cream were expected to be de minimis over the period that the Company expected it would take for XOMA to receive total payments of $ 88.0 million under the royalty purchase agreements because, unlike XACIATO, Ovaprene and Sildenafil Cream were still in development stage and not commercial assets at the time the evaluation was made.

The Company determined that the traditional royalty purchase agreement represented a complete sale of a nonfinancial asset (the Company's right, title and interest in and to future payments related to commercial sales of XACIATO) for which XOMA would bear all benefit and for which the Company had no obligations or involvement going forward, and therefore should be accounted for within the scope of ASC 610-20, Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets .

The $ 22.0 million net of transaction costs of approximately $ 1.6 million, was recorded as other income on the Company's consolidated statements of operations and comprehensive loss for the year ended December 31, 2024.

Liability Related to the Sale of Future Royalties

In December 2023, the Company entered into a royalty interest financing agreement with United in Endeavor, LLC or UiE, pursuant to which the Company sold to UiE an interest in royalty and milestone payments the Company receives based on net sales of XACIATO.

The Company received $ 5.0 million from UiE in connection with entering into the royalty interest financing agreement.

The Company evaluated the terms of the royalty interest financing agreement and concluded that its features were similar to those of a debt instrument.

The Company recognized the $ 5.0 million it received as a liability on its consolidated balance sheet because the Company agreed to make payments to UiE until such time that UiE has received aggregate payments equaling a 12 % internal rate of return on the $ 5.0 million.

Interest expense for the liability related to the sale of future royalties is recognized using the effective interest rate method over the expected term of the royalty interest financing agreement.

The liability related to the sale of future royalties and related interest expense are based on current estimates of future royalties, which estimates are based on forecasts of XACIATO net sales.

The Company periodically assesses the forecasted net sales and to the extent the amount or timing of estimated royalty payments are materially different than previous estimates, the Company will account for any such change by adjusting the liability related to the sale of future royalties and prospectively recognizing the related non-cash interest expense.

In connection with the royalty investment financing agreement the Company entered into, the Company issued a warrant to purchase up to an aggregate of 5.0 million shares of the Company's common stock.

The warrant was allocated a relative fair value of approximately $ 0.8 million using a Black-Scholes option pricing model.

The $ 0.8 million relative fair value of the warrant was recorded as a debt discount with an offset to additional paid in capital on the Company's 2023 consolidated balance sheets as the warrants were deemed to be equity classified.

Deferred Offering Costs

The Company capitalizes certain legal, professional, and other-third party charges related to its efforts to raise capital and other ongoing equity financings as deferred offering costs until fully consummated.

These costs are deferred until the completion of the offerings at which time they are reclassified to additional paid-in-capital as a reduction of the offering proceeds.

If the Company terminates the planned offering, all of the deferred offering costs will be immediately written off to operating expenses.

In October 2024, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park, under which the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $ 15.0 million of shares of the Company's common stock.

Deferred offering costs associated with the financing arrangement with Lincoln Park are reclassified to additional paid in capital on a pro-rata basis over the term of the purchase agreement.

In March 2023, the Company entered into a sales agreement to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program.

Deferred offering costs associated with the ATM equity offering program are reclassified to additional paid in capital on a pro-rata basis.

In December 2025, the Company filed an offering statement on Form 1-A for the sale of preferred stock and warrants in a Regulation A offering.

Deferred offering costs associated with this offering are reclassified to additional paid in capital on a pro-rata basis.

As of December 31, 2025 and 2024, $ 0.9 million and $ 0.7 million of deferred offering costs were capitalized on the balance sheet, respectively.

The Company determines if an arrangement is a lease at inception.

Right-of-use, or ROU, assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligations to make lease payments arising from the lease.

The Company has both operating leases for office facilities and a finance lease for laboratory space.

ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.

If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.

The ROU assets also include any lease prepayments made and exclude lease incentives.

The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option.

The Company elected the practical expedient, which allows the Company to not allocate consideration between lease and non-lease components.

In addition, the Company elected the practical expedient such that it does not recognize ROU assets or lease liabilities for leases with a term of 12 months or less.

Variable lease payments are recognized in the period in which the obligations for those payments are incurred.

Operating lease expense for lease payments is recognized on a straight-line basis over the lease term, while the finance lease results in recognition of amortization expense for the ROU asset and interest expense on the lease liability.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation.

Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally five years .

Repair and maintenance costs are charged to expense as incurred.

The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are

included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss.

Impairment of Long-Lived Assets

Long-lived assets consist primarily of property and equipment and right-of-use assets.

The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.

Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the asset or asset group are expected to generate, including its eventual residual value.

If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds its fair value.

The Company did not recognize any impairment losses for either of the years ended December 31, 2025 or 2024.

The Company recorded a loss on the disposal of a fixed asset of $ 0.6 million for the year ended December 31, 2024.

No such losses were recorded during the year ended December 31, 2025.

Risks and Uncertainties

The Company will require approvals from the FDA, or foreign regulatory agencies prior to being able to sell any products, other than compounded drugs under Section 503B of the FDCA and consumer health products that do not require a physician's prescription.

The Company received approval from the FDA for XACIATO in December 2021.

There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals.

If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and financial position.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology and product liability.

As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

Net Loss Per Share

Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents.

Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive.

There were stock options exercisable into 1,409,042 and 883,334 shares of common stock outstanding at December 31, 2025 and 2024, respectively.

There were warrants exercisable into 1,268,572 shares of common stock outstanding at each of the years ended December 31, 2025 and 2024.

These securities were not included in the computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years.

Indemnification Obligations

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Accordingly, as of December 31, 2025 and 2024, no amounts have been accrued related to such indemnification provisions.

Recently Adopted Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures, which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.

In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid.

ASU 2023-09 is effective for annual periods beginning after December 15, 2024 with early adoption permitted.

The Company adopted ASU 2023-09, on a prospective basis, on January 1, 2025, which adoption only impacted the Company's footnote disclosures with no impact on the Company's results of operations or financial condition.

See Note 8, Income Taxes, for disclosures related to the adoption of ASU 2023-09.

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses.

ASU 2024-3 requires new financial statement disclosures in tabular format, disaggregating information about prescribed categories underlying any relevant income statement expense captions.

Additionally, in January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03.

The standard provides guidance to expand disclosures related to the disaggregation of income statement expenses.

The standard requires, in the notes to the financial statements, disclosure of specified information about certain costs and expenses, which includes purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption.

This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027, on a retrospective or prospective basis, with early adoption permitted.

The Company is assessing the guidance, noting the adoption impacts disclosure only.

In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832):

Accounting for Government Grants Received by Business Entities, which establishes authoritative guidance on the recognition, measurement, presentation, and disclosure of government grants.

Under ASU 2025-10, government grants are recognized when it is probable that the entity will both comply with the conditions of the grant and the grant will be received.

The ASU provides specific accounting models for grants related to assets and grants related to income, including options to recognize government grants as deferred income or as a reduction of the asset’s cost basis.

The ASU also requires enhanced disclosures regarding the nature of government grants, significant terms and conditions, accounting policies applied, and amounts recognized in the financial statements.

ASU 2025-10 is effective for fiscal years beginning after December 15, 2028, including interim periods within those fiscal years, with early adoption permitted.

The Company is currently evaluating the impact of adopting ASU 2025-10 on its consolidated financial statements and related disclosures.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270):

Narrow-Scope Improvements, which clarifies the guidance in Topic 270 to improve the consistency of interim financial reporting.

The ASU provides a comprehensive list of required interim disclosures and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity.

ASU 2025-11 is effective for fiscal years beginning after December 15, 2027, including interim periods within those fiscal years, with early adoption permitted.

The Company is currently evaluating the impact of adopting ASU 2025-11 on its consolidated financial statements and related disclosures.

The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements.

STRATEGIC AGREEMENTS

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Organon Exclusive License Agreement

In March 2022, the Company entered into an exclusive license agreement with Organon which became effective in June 2022, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company.

In July 2022, the Company received a $ 10.0 million non-refundable and non-creditable payment from Organon, which was recorded as license fee revenue.

In July 2023, the Company received a $ 1.0 million payment from Organon in connection with the amendment to the

license agreement the parties entered into, which was also recorded as license fee revenue.

In the fourth quarter of 2023, in connection with the first commercial sale in the U.S.

of XACIATO in accordance with the license agreement, as amended, the Company received the $ 1.8 million milestone payment from Organon.

In 2022, the Company entered into an exclusive license agreement with Organon, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company.

As of December 31, 2025, the Company has received a total of $ 12.8 million in non-refundable payments, all of which have been recorded as license fee revenue in historical periods.

Under the terms of the license agreement, as amended, the Company is entitled to receive tiered double-digit royalties based on net sales and up to $ 180.0 million in tiered commercial sales milestones and regulatory milestones.

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The Company re-evaluates the transaction price at each reporting period as uncertain events are resolved and other changes in circumstances occur.

As a result of the $ 1.0 million payment in connection with the license agreement amendment and the $ 1.8 million milestone payment noted above, the transaction price was $ 12.8 million as of December 31, 2024.

As a result of a $ 1.0 million payment in connection with the license agreement amendment and a $ 1.8 million milestone payment, both of which occurred in 2023, the transaction price was $ 12.8 million as of December 31, 2025.

The Company will recognize any consideration related to sales-based payments, including milestones and royalties which relate predominantly to the license granted, at the later of (i) when or as the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Generally, because sales-based payments are required to be paid more than 45 days after the end of each quarter, other than with respect to the fourth quarter, the Company estimates sales-based payments it will recognize for a particular quarter based on an analysis of historical experience and the Company's estimated gross sales and customary deductions for the applicable quarter.

To date, it has been challenging for the Company to accurately estimate the amount of the sales-based payments for a particular quarter due to limited historical information available to the Company to inform such estimates.

Differences between actual and estimated sales-based payments will be adjusted for in the quarter in which the actual amount becomes known, which is generally expected to be the following quarter.

Refer to Note 13, Royalty Purchase Agreements, regarding the Company's sale to XOMA of all the Company's right, title and interest in and to, from and after April 1, 2024, all net royalty and potential net milestone payments from Organon based on net sales of XACIATO.

The Company was responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumed such responsibilities, which occurred in December 2023.

Prior to that time, Organon purchased all of its product requirements of XACIATO from the Company at a transfer price equal to the Company's manufacturing costs plus a single-digit percentage markup.

Unless terminated earlier, the agreement will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product.

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In January 2020, the Company entered into a license agreement with Bayer, regarding the further development and commercialization of Ovaprene in the U.S.

The Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer and Bayer agreed to support the Company in development and regulatory activities by providing the equivalent of two experts to advise the Company in clinical, regulatory, preclinical, commercial, CMC and product supply matters.

The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations.

Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $ 20.0 million, referred to as the $ 20.0 million fee.

After payment of the $ 20.0 million fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S.

Such license would be exclusive as to the commercialization of Ovaprene for human contraception in the U.S.

and co-exclusive with the Company with regard to development.

The Company concluded there was one significant performance obligation related to the $ 1.0 million upfront payment:

a distinct license to commercialize Ovaprene effective upon the receipt of the $ 20.0 million fee.

The $ 1.0 million upfront payment will be recorded as license revenue at the earlier of (i) the point in time the Company receives the $ 20.0 million fee, the license is transferred to Bayer and Bayer is able to use and benefit from the license and (ii) the termination of the agreement.

As of December 31, 2024, neither of the foregoing had occurred.

The $ 1.0 million payment is recorded as non-current deferred license revenue in the Company's consolidated balance sheets at December 31, 2024 and 2023.

If Bayer elects to make the license effective, the Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S.

and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $ 310.0 million if all such milestones, including the first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based

on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue.

Refer to Note 13, Royalty Purchase Agreements, regarding XOMA's rights to a portion of potential future payments from Bayer under the Company's license agreement with Bayer.

The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.

or 15 years from the first commercial sale of Ovaprene in the U.S.

In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the $ 20.0 million fee if and when due.

In November 2025, the Company received notice from Bayer that it was terminating the license agreement.

The Company and Bayer mutually agreed to terminate the agreement effective as of December 2, 2025.

In connection with entering into the license agreement, the Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer, which was recorded as license revenue when the agreement was terminated.

Significant Accounting Policies—Revenue Recognition—Bayer License, above.

Strategic Agreements for Pipeline Development

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patents Theramex recently acquired for Casea S.

Given that the product is in an ongoing Phase 1 study that is funded by a grant, there are no development costs for the Company or Theramex at this time.

The license fee paid by the Company during the first quarter of 2025 was recorded as research and development expense.

Given that the product is in an ongoing Phase 1 study funded by a grant, there are no development costs for the Company or Theramex at this time.

If the Company determines that the results from the study are positive, it would be responsible for conducting a Phase II study in the U.S., and funding for such study and for a future Phase III study in the U.S.

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Douglas License Agreement / The University of Manchester Stand-by Direct License Arrangement

In August 2023, the Company entered into a license agreement with Douglas Pharmaceuticals Limited, or Douglas, under which the Company acquired the exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of cervical intraepithelial neoplasia and other HPV-related pathologies, and an agreement with The University of Manchester, pursuant to which The University of Manchester consented to Douglas' sublicense to the Company of certain rights it previously granted to Douglas and agreed to grant the Company a direct license to such rights if its license agreement with Douglas is terminated.

In August 2023, the Company entered into a license agreement with Douglas Pharmaceuticals Limited, or Douglas, under which the Company acquired the exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of cervical intraepithelial neoplasia and other HPV-related pathologies, and an agreement with The University of Manchester, pursuant to which The University of Manchester

consented to Douglas' sublicense to the Company of certain rights it previously granted to Douglas and agreed to grant the Company a direct license to such rights if its license agreement with Douglas is terminated.

Under the Company's agreement with Douglas, it received an exclusive, royalty-bearing license to research, develop and commercialize the licensed intellectual property in the United States for the treatment or prevention of all indications for women in female reproductive health.

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The Company is entitled to sublicense the rights granted to it under the agreement.

Under the terms of the license agreement, the Company agreed to make potential future payments of up to $ 6.25 million in the aggregate upon achievement of certain development and regulatory milestones, and up to $ 45.0 million in the aggregate upon achievement of certain commercial sales milestones for each product covered by

the licenses granted under the agreement, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

Under the terms of the license agreement, the Company agreed to make potential future payments of up to $ 6.25 million in the aggregate upon achievement of certain development and regulatory milestones, and up to $ 45.0 million in the aggregate upon achievement of certain commercial sales milestones for each product covered by the licenses granted under the agreement, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

Additionally, Hennepin is eligible to receive tiered royalties in low single-digit to low double-digit percentages based on worldwide net sales of products and processes covered by the licenses granted under the agreement.

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In November 2019, the Company acquired Dare MB Inc., or MBI, to secure the rights to develop a long-acting reversible contraception method, that a woman can turn on or off herself, according to her own needs.

This candidate is now known as DARE-LARC1.

This candidate is now known as DARE-LARC1 and the drug delivery technology underlying DARE-LARC1 is now known as the Company's intelligent drug delivery system platform, DARE-IDDS.

Under the terms of the merger agreement, the Company agreed to pay former MBI stockholders:

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and (c) tiered royalty payments ranging from low single-digit to low double-digit percentages based on annual net sales of such products sold by the Company (but not by sublicensee) and a percentage of sublicense revenue related to such products.

In June 2021, a total of $ 1.25 million of the contingent consideration became payable upon the achievement of certain of the funding and product development milestone events.

In accordance with the terms of the merger agreement, the Company’s board of directors elected to pay a portion of these milestone payments in shares of the Company’s common stock, and in September 2021, the Company issued approximately 58,334 shares of its common stock to former stockholders of MBI and paid $ 75,000 in cash to the stockholders’ representative in satisfaction of the $ 1.25 million in milestone payments associated with milestones achieved in June 2021.

In 2021, a total of $ 1.25 million of the contingent consideration became payable, $ 75,000 of which was paid in cash and the balance of which was paid in shares of the Company's common stock, as permitted by the terms of the merger agreement.

As of December 31, 2025, no additional payments have been made under this agreement.

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Both agreements relate to the Exclusive License Agreement among Hammock, TriLogic and MilanaPharm dated as of January 9, 2017, or the MilanaPharm License Agreement.

Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, the Company acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications.

Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, the Company acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop

and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications.

The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726.

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In September 2021, the Company entered into a second amendment to the License Agreement.

In March 2022, the Company entered into a Consent, Waiver and Stand-By License Agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement.

In 2022, the Company entered into a Consent, Waiver and Stand-By License Agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement.

Under the terms of the License Agreement, the Company paid clinical and regulatory development milestones of $ 300,000 in the aggregate to MilanaPharm, the final payment of which was made in 2021, and $ 500,000 in connection with the first commercial sale in the United States of XACIATO in the fourth quarter of 2023.

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Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm license agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan.

Hammock is eligible to receive up to $ 1.1 million

in the aggregate upon achievement of certain clinical and regulatory development milestones, $ 850,000 of which had been paid as of December 31, 2024.

Hammock is eligible to receive up to $ 1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones, $ 850,000 of which had been paid as of December 31, 2025.

Pear Tree Acquisition

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Catalent JNP License Agreement

In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc., or Catalent, under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes, and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes.

In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc., or Catalent, under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes, and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and

have imported products and processes.

As a result of this license agreement, the Company commenced its DARE-HRT1, DARE-FRT1 and DARE-PTB1 programs.

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In lieu of such royalty payments, the Company will pay Catalent a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the agreement to a third party.

As of December 31, 2025, no such payments have been made under this agreement.

Adare Development and Option Agreement

In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals USA, Inc., or Adare, for the development and potential exclusive worldwide license of injectable formulations of etonogestrel for contraceptive protection over 6-month and 12-month periods (which the Company

refers to as DARE-204 and DARE-214, respectively).

In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals USA, Inc., or Adare, for the development and potential exclusive worldwide license of injectable formulations of etonogestrel for contraceptive protection over 6-month and 12-month periods (which the Company refers to as DARE-204 and DARE-214, respectively).

The agreement, as amended, provides the Company with an option to negotiate an exclusive, worldwide, royalty-bearing license, with rights to sublicense, for the programs if the Company funds the conduct of specified development work.

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Additionally, SST is eligible to receive tiered royalties based on percentages of annual net sales of licensed products in the single-digit to mid double-digits subject to customary royalty reductions and offsets, and a percentage of sublicense revenue.

As of December 31, 2024, $ 1.0 million became payable under this agreement and was subsequently paid in February 2025.

As of December 31, 2025, $ 1.0 million has been paid under this agreement, which was paid in February 2025.

ADVA-Tec License Agreement

In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., or ADVA-Tec, under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide.

Under the terms of the license agreement, the Company will pay ADVA-Tec (a) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $ 1.2 million of which has been paid;

and (b) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones.

Under the terms of the license agreement, the Company will pay ADVA-Tec (a) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, and (b) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones.

As of December 31, 2025, $ 1.2 million in milestone payments have been paid.

Additionally, ADVA-Tec is eligible to receive royalties based on aggregate annual net sales of Ovaprene in specified regions at a royalty rate that will vary between 1 % and 10 % and will increase based on various net sales thresholds, subject to customary reductions and offsets.

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provided, however, that for sublicense revenue the Company receives prior to the first commercial sale of a licensed product that represents an upfront payment or license fee due on or around the effective date of the sublicense, ADVA-Tec is eligible to receive a single-digit percentage of that sublicense revenue.

As of December 31, 2024, only the $ 1.2 million in aggregate milestone payments noted above have been made.

PREPAID EXPENSES

Prepaid expenses consisted of the following:

PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following:

As of December 31,

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Prepaid legal and professional expenses 206,981 166,429

Total prepaid expenses $ 2,519,707 $ 6,118,272

Deferred offering costs 321,686 —

Other current assets 65,405 —

Other receivables 573,061 229,982

Total prepaid expenses and other current assets $ 2,352,523 $ 2,749,689

PROPERTY AND EQUIPMENT, NET

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$ 1,558,890 $ 1,335,732

Depreciation expense was $ 42,325 and $ 38,363 for the years ended December 31, 2024 and 2023, respectively.

Depreciation expense was approximately $ 162,000 and $ 42,000 for the years ended December 31, 2025 and 2024, respectively.

ACCRUED EXPENSES

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As of December 31,

Accrued clinical expense $ — $ 1,195,744

Accrued compensation and benefits $ 10,261 $ 805,612

Accrued development expense 447,466 1,258,435

Accrued royalties payable — 6,504

Insurance financing payable 182,521 249,628

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VENDOR CONCENTRATION

The Company had two major vendors that accounted for approximately 15 % and 12 % of the Company's research and development expenditures for the year ended December 31, 2024, and 21 % and 3 % of the Company's research and development expenditures for the year ended December 31, 2023.

The same vendors accounted for 0 % of the Company's total accounts payable and accrued expenses as of each of December 31, 2024 and 2023.

The Company had five major vendors that accounted for approximately 27 %, 20 %, 17 %, 16 % and 10 % of the Company's research and development expenses for the year ended December 31, 2025, and 3 %, 2 %, 0 %, 2 % and 6 % of the Company's research and development expenditures for the year ended December 31, 2024.

The same vendors accounted for 7 % and 3 % of the Company's total accounts payable and accrued expenses as of each of December 31, 2025 and 2024, respectively.

The Company continues to maintain its relationship with these vendors and anticipates incurring significant expenses with these vendors over the next 12 months.

The components of loss from continuing operations before provision for income taxes consists of the following (in thousands):

The components of the loss from continuing operations before provision for income taxes consists of the following (in thousands):

Years Ended December 31,

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The difference between the provision (benefit) for income taxes and the amount computed by applying the U.S.

federal income tax rate for the years ended December 31, 2024 and 2023 are as follows:

federal income tax rate for the year ended December 31, 2025 is as follows (in thousands):

Years Ended December 31,

Federal statutory rate 21.0 % 21.0 %

Income taxes (benefit) at statutory rates $ ( 2,844 ) 21.0 %

State income tax (benefit), net of federal benefit (1)

Foreign tax effects

Research credit 984 ( 7.3 ) %

Change in Valuation Allowance ( 950 ) 7.0 %

Other 12 ( 0.1 ) %

Effect of changes in tax laws or rates enacted in the current period — — %

Research and development credit ( 732 ) 5.4 %

Changes in valuation allowance ( 50 ) 0.4 %

Nontaxable or nondeductible items

Permanent items 865 ( 6.4 ) %

Officers' compensation 475 ( 3.5 ) %

Stock compensation 1,761 ( 13.0 ) %

Changes in unrecognized tax benefits 71 ( 0.5 ) %

Expiration of attributes 229 ( 1.7 ) %

Other 104 ( 0.7 ) %

(1) The states that contributed to the majority (greater than 50%) of the tax effect in this category include California and Massachusetts.

As previously disclosed, prior to the adoption of ASU 2023-09, the difference between the provision (benefit) for income taxes and the amount computed by applying the U.S.

federal income tax rate for the year ended December 31, 2024 is as follows:

Federal income tax expense at statutory rate 21.00 %

State income tax, net of federal benefit ( 3.75 ) %

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Effective income tax rate — %

During 2025, the Company identified an immaterial error in the Company’s deferred tax assets and corresponding valuation allowance as of December 31, 2024, relating to capitalized research and development costs which resulted in understated deferred tax assets and corresponding valuation allowance of approximately $ 0.9 million .

For comparative purposes, the Company’s 2024 tax disclosures herein have been revised to reflect the adjustment to the deferred tax assets and valuation allowance.

The Company evaluated the error and concluded the impact was not material to its consolidated financial statements.

The effect of the revision to the net deferred tax asset balance was zero, and the revision had no impact on the Company’s consolidated balance sheet, consolidated statement of operations and comprehensive loss or consolidated statement of cash flows.

The major components of the Company’s deferred tax assets as of December 31, 2025 and 2024 are shown below (in thousands).

Deferred tax assets:

Net operating loss carryforwards $ 98,463 $ 85,686

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Stock compensation 674 3,570

Other 1,546 306

Total deferred tax assets 114,406 115,778

Valuation allowance ( 113,743 ) ( 115,532 )

Net deferred tax assets $ — $ —

Deferred tax assets, net of valuation allowance 663 246

Deferred tax liabilities:

Right-of-use assets ( 654 ) ( 246 )

Other ( 9 ) —

Total deferred tax liabilities ( 663 ) ( 246 )

Net deferred tax assets (liabilities) $ — $ —

The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets.

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When and if management determines that it is more likely than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated.

The increase in valuation allowance of approximately $ 2.4 million and $ 8.0 million for the years ended December 31, 2024 and 2023, respectively, is primarily related to an increase in net operating losses and R&D credits generated during the year and changes in state tax rates.

The Company has U.S.

federal net operating loss, or NOL, carryforwards available at December 31, 2024 of approximately $ 315.2 million of which $ 1.1 million begin expiring in 2025 unless previously utilized and $ 139.8 million that do not expire.

The Company has state NOL carryforwards of $ 298.4 million that begin expiring in 2031 unless previously utilized.

The Company has U.S.

federal research credit carryforwards available at December 31, 2024 of approximately $ 11.6 million that begin expiring in 2027 unless previously utilized.

The Company has state research credit carryforwards of $ 2.5 million of which $ 0.2 million begin expiring in 2027 unless previously utilized.

These federal and state research and development credits are subject to a 20% reserve under FASB ASC 740.

The difference between federal and state NOL carryforwards is primarily due to previously expired state NOL carryforwards.

Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future.

These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.

The Company has not yet completed an evaluation of ownership changes.

To the extent an ownership change occurs, the NOL and credit carryforwards and other deferred tax assets may be subject to limitations.

The valuation allowance decreased by approximately $ 1.8 million for the year ended December 31, 2025.

At December 31, 2025, the Company had federal, state and Australian net operating loss carryforwards of $ 369.4 million, $ 305.9 million, and $ 2.4 million, respectively, some of which will begin expiring in 2026 unless previously utilized.

Included in the federal net operating loss carryforward is $ 195.8 of federal carryforward with no expiration date.

The Australian losses may be carried forward indefinitely as well.

The Company also had federal and state research and development credit carryforwards of $ 13.3 million and $ 2.7 million, respectively.

The federal research and development credit carryforwards will begin expiring in 2027 , unless previously utilized.

The state research credits begin to expire in 2027 , unless previously utilized.

Included in the state research credit carryforward is $ 0.6 million of carryforward with no expiration date.

The Australian credits may be carried forward indefinitely as well.

Future utilization of the Company's net operating loss and research and development credit carryforwards to offset future taxable income may be subject to an annual limitation, pursuant to Internal Revenue Code (IRC) Section 382 and 383, as a result of ownership changes that may have occurred or that could occur in the future.

An ownership change occurs when a cumulative change in ownership of more than 50% occurs within a three-year period.

The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards.

If a change in ownership were to have occurred or occurs in the future, the use of NOL and tax credits carryforwards may be limited or reduced.

The Company does not expect this analysis to be completed within the next 12 months.

If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance.

Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, will not impact the Company's effective tax rate.

The Company accounts for income taxes in accordance with authoritative accounting guidance which states the impact of an uncertain income tax position is recognized at the largest amount that is "more likely than not" to be sustained upon audit by the relevant taxing authority.

An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained.

A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands):

Years Ended December 31,

Beginning uncertain tax benefits $ 2,617 $ 2,316

Current year - increases 237 347

Prior year - reductions ( 30 ) ( 46 )

Ending uncertain tax benefits $ 2,824 $ 2,617

Included in the balance of uncertain tax benefits at December 31, 2024 are $ 2.8 million of tax benefits that, if recognized, would result in a reduction of the gross deferred tax asset, offset fully by valuation allowance and have no net impact on the financial statements.

The Company anticipates that no material amounts of unrecognized tax benefits will be settled within 12 months of the reporting date.

Beginning balance uncertain tax benefits $ 3,067 $ 2,761

Decreases related to prior year positions — ( 31 )

Additions related to prior year positions 59 —

Additions related to current year positions 65 337

Decreases related to settlements with taxing authorities — —

Decreases as a result of a lapse of the applicable statute of limitations — —

Ending balance of unrecognized tax benefits $ 3,191 $ 3,067

Included in the balance of uncertain tax benefits at December 31, 2025 and 2024 are $ 3.1 million and $ 2.9 million of tax benefits that, if recognized, would result in a reduction of the gross deferred tax asset, offset fully by valuation allowance and have no net impact on the financial statements.

The Company's policy is to record estimated interest and penalties related to uncertain tax benefits as income tax expense.

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net operating losses utilized in future years will remain open beginning in the year of utilization.

No additional provision has been made for U.S.

income taxes related to undistributed foreign earnings of the Company’s wholly-owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences related to investments in subsidiaries.

As such, earnings are expected to be permanently reinvested, the investments are permanent in duration, or the Company has estimated that no additional tax liability will arise as a result of the distribution of such earnings.

A liability could arise if amounts are distributed by the subsidiary or if the subsidiary is ultimately disposed.

It is not practical to estimate the additional income taxes, if any, related to permanently reinvested earnings.

There are no unremitted earnings as of December 31, 2024.

There are currently no pending income tax examinations.

On July 4, 2025, the One Big Beautiful Bill Act (the "Act") was signed into law.

The Act reinstates and makes permanent 100% first-year bonus depreciation under Section 168(k) for qualified property acquired and placed in service after January 19, 2025.

Additionally, the Act allows current expensing of domestic research and experimental costs starting in 2025 and provides special retroactive relief for "smaller business taxpayers." The Company deducted the unamortized R&E expenditures as of December 31, 2024 on its 2024 tax return, resulting in no change in the Company's effective tax rate or cash tax liability due to the full valuation allowance.

The Company has reflected the effects of the Act in its income tax provision in accordance with ASC 740 and there was no material impact.

STOCKHOLDERS’ EQUITY

Reverse Stock Split

On July 1, 2024, the Company effected a 1-for-12 reverse split of its issued common stock.

At the effective time of the r everse stock split , every 12 shares of the Company’s common stock was automatically reclassified and combined into one share of common stock.

No fractional shares were issued as a result of the reverse stock split.

Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share.

The reverse stock split reduced the number of issued and outstanding shares of the Company’s common stock from approximately 101.1 million to approximately 8.5 million .

The reverse stock split did not change the number of authorized shares or the par value per share of the Company’s common stock.

On October 21, 2024, the Company entered into a purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park.

Under the terms and subject to the conditions of the purchase agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $ 15.0 million of the Company’s common stock.

Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 24-month period commencing on November 27, 2024.

Under the terms and subject to the conditions of the purchase agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $ 15.0 million of shares of the Company’s common stock.

Sales of such shares by the Company, if any, are subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 24-month period commencing on November 27, 2024, which is referred to as the "Commencement Date."

From time to time after the Commencement Date, at the Company’s sole discretion, on any business day selected by the Company on which the closing sale price of the Company’s common stock is not below $ 0.50 per share, the Company may direct Lincoln Park to purchase up to 30,000 shares of the Company’s common stock (or up to 35,000 and 40,000 shares if the closing sale price of the Company’s common stock on the day on which the Company initiates a purchase is not below $ 5.00 or $ 7.50 , respectively, subject to customary adjustments for stock splits and similar transactions) at a purchase price equal to the lower of (i) the lowest sale price of the Company’s common stock on the business day on which the Company initiates the purchase and (ii) the average of the three lowest closing sale prices of the Company’s common stock during the 10 -business day period immediately preceding the business day on which the Company initiates the purchase.

However, Lincoln Park’s maximum commitment in any single purchase may not exceed $ 500,000 .

In addition, the Company may also direct Lincoln Park to purchase other amounts of common stock as accelerated purchases and as additional accelerated purchases, subject to limits specified in the purchase agreement, at a purchase price per share calculated as specified in the purchase agreement, but in no case lower than the minimum price per share the Company stipulates in its notice to Lincoln Park initiating these purchases.

In addition, under applicable Nasdaq rules, the Company may not issue or sell to Lincoln Park under the purchase agreement more than 1,711,172 shares of the Company’s common stock, which is referred to as the Exchange Cap, unless (i) the Company obtains stockholder approval to issue shares in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the purchase agreement equals or exceeds $ 3.59 per share (which represents the lower of (A) the official closing price per share of the Company’s common stock on Nasdaq immediately preceding the signing of the purchase agreement and (B) the average official closing price of the Company’s common stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the purchase agreement).

The Company may also not sell shares to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 4.99 % of the Company’s then outstanding shares of common stock, which limitation is referred to as the beneficial ownership cap.

Lincoln Park, upon written notice to the Company, may increase the beneficial ownership cap to up to 9.99 %.

Any increase in the beneficial ownership cap will not be effective until the 61st day after such written notice is delivered to the Company.

In connection with entering into the purchase agreement, the Company issued 137,614 shares of its common stock to Lincoln Park in consideration for its commitment to purchase shares thereunder.

September 2023 Registered Direct Offering

In August 2023, the Company entered into a securities purchase agreement with an institutional investor and an investor affiliated with Douglas for the purchase and sale of 833,334 shares of the Company's common stock and warrants to purchase additional shares of the Company's common stock in a registered direct offering priced at-the-market under Nasdaq rules.

The offering closed on September 1, 2023.

Each warrant is exercisable for one share of

the Company's common stock.

The terms of the warrants are further described below in this Note 9.

The offering price was $ 8.40 per share of common stock and accompanying warrant.

The aggregate gross proceeds to the Company from the offering were $ 7.0 million, and net proceeds were approximately $ 7.0 million.

The offering was made pursuant to the Company's registration statement on Form S-3 (File No.

333-254862), filed with the SEC on March 30, 2021, and declared effective by the SEC on April 7, 2021, and a prospectus supplement thereunder.

During the year ended December 31, 2025, the Company sold 1,470,000 shares of common stock under this agreement for gross proceeds of approximately $ 3.3 million, net of offering expenses of approximately $ 0.1 million.

March 2023 ATM Sales Agreement

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In April 2024, the Company and Cantor mutually agreed to terminate the sales agreement with respect to Cantor.

Through and including May 10, 2024, shares of the Company's common stock sold under the sales agreement were offered and sold under the Company's shelf registration statement on Form S-3 (File No.

333-254862), the base prospectus included therein, originally filed with the SEC on March 30, 2021 and declared effective by the SEC on April 7, 2021, and the prospectus supplements thereto, the most recent of which was dated March 28, 2024 relating to the offering of up to $ 19.0 million of shares of the Company's common stock.

From and after May 11, 2024, shares of the Company's common stock sold under the sales agreement were and will be offered and sold under the Company's shelf registration statement on Form S-3 (File No.

333-278380), the base prospectus included therein, originally filed with the SEC on March 29, 2024 and declared effective by the SEC on May 10, 2024, the prospectus supplement thereto dated May 10, 2024 relating to the offering of up to $ 18.1 million of shares of the Company's common stock, and any subsequent prospectus supplement related to the offering of shares of the Company's common stock under the sales agreement.

During the years ended December 31, 2024 and 2023, the Company sold 109,655 and 316,244 shares of common stock, respectively, under the sales agreement for net proceeds of approximately $ 0.5 million and $ 2.3 million, respectively.

During the years ended December 31, 2025 and 2024, the Company sold 4,329,116 and 109,655 shares of common stock, respectively, under the sales agreement for aggregate gross proceeds of approximately $ 18.0 million and $ 0.5 million, respectively, net of offering expenses of approximately $ 0.4 million and $ 11,000 , respectively.

Common Stock Warrants

December 2023 Warrants

In connection with the royalty interest financing agreement the Company entered into in December 2023, the Company issued a warrant to purchase up to an aggregate of 422,805 shares of the Company's common stock.

The warrant has a term of five years from the date of issuance and an exercise price of $ 4.10 per share, subject to customary adjustment for stock splits and similar transactions.

A holder (together with its affiliates) may not exercise any portion of the warrant to the extent that the holder would own more than 4.99 % (or, at the election of the holder 9.99 %) of the Company's outstanding common stock immediately after exercise.

The warrant includes certain rights in favor of the holder upon a “fundamental transaction” as described in the warrant, including the right of the holder to receive from the Company or the successor entity an amount of cash equal to the Black-Scholes value (as described in the warrants) of the unexercised portion of the warrant on the date of the consummation of such fundamental transaction.

The warrant was allocated a value of $ 0.8 million using a Black-Scholes option pricing model based on the relative fair value method.

The Black-Scholes model used the following assumptions:

expected volatility:

risk-free interest rate:

expected dividend yield:

and expected term:

The warrant was deemed to be classified as equity and recorded within additional paid in capital on the consolidated balance sheets.

As of December 31, 2024, no portion of the warrant had been exercised.

The warrants outstanding as of December 31, 2025, are exercisable into 1,268,572 shares of common stock which had a fair value of $ 1.93 per share, based on the closing market price of the Company's common stock on December 31, 2025.

The aggregate intrinsic value of warrants outstanding as of December 31, 2025, is calculated as

the difference between the exercise price of the warrants and the closing market price of the Company's common stock on that date.

The intrinsic value of warrants outstanding as of December 31, 2025, was zero.

The Company has performed an assessment of all warrants issued and determined that the Company's warrants are equity-classified.

Summary of Warrants Outstanding

A summary of warrants outstanding during the years ended December 31, 2025 and 2024 is presented below:

Quantity of Warrants Outstanding as of

Description December 31, 2025 December 31, 2024 Exercise Price Expiration Date

Initial Royalty Warrant (1)*

422,804 422,804 $ 4.10 12/22/2028

September 2023 Warrants (2)*

In connection with the registered direct offering completed in September 2023, the Company issued warrants to purchase up to an aggregate of 845,225 shares of the Company's common stock.

The warrants became exercisable on March 1, 2024, expire March 1, 2029 and have an exercise price of $ 9.11 per share, subject to customary adjustment for stock splits and similar transactions.

A holder (together with its affiliates) may not exercise any portion of a warrant to the extent that the holder would own more than 4.99 % (or, at the election of the holder 9.99 %) of the Company's outstanding common stock immediately after exercise.

The warrants include certain rights in favor of the holders upon a “fundamental transaction” as described in the warrants, including the right of the holders to receive from the Company or the successor entity an amount of cash equal to the Black-Scholes value (as described in the warrants) of the unexercised portion of the warrants on the date of the consummation of such fundamental transaction.

The warrants were allocated a value of $ 2.9 million using a Black-Scholes option pricing model based on the relative fair value method as they were issued with common stock.

The Black-Scholes model used the following assumptions:

expected volatility:

risk-free interest rate:

expected dividend yield:

and expected term:

The warrants were deemed to be classified as equity and recorded within additional paid in capital on the consolidated balance sheets.

As of December 31, 2024, none of the warrants have been exercised.

February 2018 Warrants

In connection with an underwritten public offering in February 2018, the Company issued to the investors in that offering, warrants exercisable through February 2023 with an initial exercise price of $ 36.00 per share.

The Company estimated the fair value of the warrants as of February 15, 2018 to be approximately $ 3.0 million which was recorded in equity as of the issuance date.

The warrants included a price-based anti-dilution provision, which resulted in automatic reductions to the exercise price of the warrants in April 2019 and July 2020 to $ 11.76 per share and $ 11.52 per share, respectively.

In January 2023, warrants to purchase 112,793 shares of common stock were exercised for gross proceeds of approximately $ 1.3 million and the remaining unexercised warrants expired in February 2023.

Summary of Warrant Activity

A summary of warrant activity during the years ended December 31, 2024 and 2023 is presented below:

Number of Shares Underlying Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value

Outstanding, December 31, 2022

845,225 845,225 $ 9.11 3/1/2029

Granted 1,268,030

Exercised ( 112,793 )

Forfeited or expired ( 1,750 )

Outstanding, December 31, 2023

October 2016 Warrants (3)

542 542 $ 120.00 10/4/2026

Exercised — —

Forfeited or expired — —

Outstanding and exercisable, December 31, 2024

Total Warrants Outstanding

1,268,571 1,268,571

1) Refers to a warrant issued in connection with entering into the royalty interest financing agreement with UiE.

2) Refers to the warrants issued in connection with a registered direct offering the Company completed in September 2023.

3) Refers to a warrant issued in October 2016 to a former financial advisor.

* The warrant includes certain rights in favor of the holder upon a "fundamental transaction" as described in the warrant, including the right of the holder to receive from the Company or the successor entity an amount of cash equal to the Black-Scholes value (as described in the warrants) of the unexercised portion of the warrant on the date of the consummation of such fundamental transaction.

The authorized capital of the Company consists of 240,000,000 shares of common stock with a par value of $ 0.0001 per share and 5,000,000 shares of preferred stock with a par value of $ 0.01 per share.

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Total 3,217,657

Reverse Stock Split

On July 1, 2024, the Company effected a 1-for-12 reverse split of its issued common stock.

At the effective time of the r everse stock split , every 12 shares of the Company’s common stock was automatically reclassified and combined into one share of common stock.

No fractional shares were issued as a result of the reverse stock split.

Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share.

The reverse stock split reduced the number of issued and outstanding shares of the Company’s common stock from approximately 101.1 million to approximately 8.5 million .

The reverse stock split did not change the number of authorized shares or the par value per share of the Company’s common stock.

STOCK-BASED COMPENSATION

2014 Employee Stock Purchase Plan

The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, became effective in April 2014, but no offering period has been initiated thereunder since January 2017.

In June 2024, the Company's board of directors suspended the ESPP.

The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, was suspended in June 2024.

There was no stock-based compensation related to the ESPP for the years ended December 31, 2025 or December 31, 2024.

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The Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan, provided for the grant of stock-based awards to employees, directors, consultants and advisors.

As a result of the approval of the 2022 Plan (as defined below) by the Company's stockholders on June 23, 2022, no further awards have been or will be granted under the Amended 2014 Plan since June 23, 2022.

As a result of the approval of the 2022 Plan (as defined below) by the Company's stockholders in June 2022, no further awards have been or will be granted under the Amended 2014 Plan since such approval.

Outstanding awards previously granted under the Amended 2014 Plan continue to remain outstanding in accordance with their terms.

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In April 2022, the Company's board of directors approved the Daré Bioscience, Inc.

2022 Stock Incentive Plan, or the 2022 Plan, which was subsequently approved by the Company's stockholders on June 23, 2022, and became effective as of that date.

2022 Stock Incentive Plan, or the 2022 Plan, which was subsequently approved by the Company's stockholders in June 2022, and became effective as of such approval.

In April 2025, the Company's board of directors approved an amendment to the 2022 Plan to increase the number of shares of common stock available for issuance thereunder by 600,000 , which was subsequently approved by the Company's stockholders on July 9, 2025.

The 2022 Plan provides for the grant of stock-based incentive awards to employees, directors, consultants, and advisors.

The number of shares of common stock authorized for issuance under the 2022 Plan is (a) 843,108 ;

plus (b) up to 512,056 shares subject to awards granted under the Amended 2014 Plan or the 2007 Stock Incentive Plan that expire, terminate or are otherwise forfeited on or after June 23, 2022.

As of December 31, 2025, the number of shares of common stock authorized for issuance under the 2022 Plan was 1,949,085 , which is the sum of:

(a) 540,043 shares available for awards that may be granted under the 2022 Plan;

(b) 1,015,783 shares underlying awards granted under the 2022 Plan, plus

(c) 393,259 shares underlying awards granted under the Amended 2014 Plan, which if they expire, terminate or are otherwise forfeited will become available for issuance under the 2022 Plan.

Options granted are exercisable at various dates as determined upon grant and will expire no more than ten years from their date of grant.

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Exercised — —

Cancelled/forfeited ( 525 ) 14.07

Expired ( 29 ) 13.92

Outstanding at December 31, 2023 788,569 17.50

Granted 228,060 5.45

Exercised — —

Canceled/forfeited ( 765 ) 3.18

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*The aggregate intrinsic value is the sum of the amounts by which the quoted market price of the Company's common stock exceeded the exercise price of the stock options at December 31, 2025 for those stock options for which the quoted market price was in excess of the exercise price.

The weighted average grant-date fair value of stock options granted during at December 31, 2024 and 2023 was $ 4.10 and $ 11.28 , respectively.

Compensation Expense

The weighted average grant-date fair value of stock options granted during the years ended December 31, 2025 and 2024 was $ 2.02 and $ 4.10 , respectively.

The total fair value of stock options vested during the years ended December 31, 2025 and 2024, was approximately $ 1.5 million and $ 2.2 million, respectively.

Stock-Based Compensation Expense

Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations and comprehensive loss is as follows:

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Research and development $ 636,303 $ 833,689

General and administrative 1,369,567 1,707,536

Selling, general and administrative

860,259 1,369,567

Total $ 1,496,562 $ 2,203,256

The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of their service on the Company's board of directors during the years ended December 31, 2024 and 2023 is as follows:

The weighted-average assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of their service on the Company's board of directors during the years ended December 31, 2025 and 2024 is as follows:

Expected life in years 5.8 6.0

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LEASED PROPERTIES

Clean Room Space

On July 24, 2024, the Company entered into a scope of work (the "SOW") with an unrelated third party for a controlled clean room space in Burlington, Massachusetts.

The SOW became effective upon the execution of an associated License and Services Agreement, which governs the SOW.

The term of the SOW is 22 months and commenced on March 1, 2025.

Upon execution of the SOW, the Company made a payment of approximately $ 459,000 .

Fixed payments will be due at the beginning of each calendar quarter and variable amounts related to support services will be due monthly based on services provided during the preceding month.

The Company's total

obligation in respect of the fixed payments due under the SOW is approximately $ 3.5 million.

The SOW may be renewed each year and if renewed, the fixed payment amount may increase yearly by up to 5 %.

General Office Space

The Company's lease for its corporate headquarters ( 3,169 square feet of office space) commenced on July 1, 2018.

In February 2022, the Company entered into an amendment to extend the term of the lease through August 31, 2024.

On March 8, 2024, the Company entered into another amendment to extend the term of the lease for three years such that the term now expires on October 31, 2027, which resulted in additional operating lease liabilities and ROU assets of approximately $ 0.4 million in March 2024.

MBI, a wholly-owned subsidiary the Company acquired in November 2019, leases general office and laboratory space in Lexington, Massachusetts.

The lease commenced on November 1, 2023 for a term of three years , expiring on December 31, 2026, and resulted in an increase in operating lease liabilities and ROU assets of approximately $ 0.4 million.

Finance Lease - Clean Room Space

On July 24, 2024, the Company entered into a scope of work (the "SOW") with an unrelated third party for a controlled clean room space in Massachusetts.

The SOW became effective upon the execution of an associated License and Services Agreement (the "LSA"), which governs the SOW.

On February 25, 2025, the parties entered into a termination agreement related to the original LSA and SOW and concurrently entered into a revised LSA and revised SOW, collectively, the Clean Room Agreement, primarily to clarify the location of the clean room subject to the arrangement.

The term of the Clean Room Agreement is 22 months and commenced on March 1, 2025.

Fixed payments are due at the beginning of each calendar quarter and variable amounts related to support services are due monthly based on services provided during the preceding month.

Upon execution of the SOW, the Company made a prepayment of approximately $ 459,000 .

The Clean Room Agreement may be renewed each year and if renewed, the fixed payment amount may increase yearly by up to 5 %.

The Company determined that the Clean Room Agreement is a finance lease.

On the commencement date, the Company recorded an initial finance lease ROU asset and related lease liability of approximately $ 3.3 million and $ 2.8 million, respectively.

Included in the $ 3.3 million finance ROU asset is the $ 459,000 prepayment which was reclassified to the finance lease ROU asset on the commencement date.

The lease does not provide an implicit rate and therefore the Company used its incremental borrowing rate as the discount rate when measuring the finance lease liability.

The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment.

The Company used an incremental borrowing rate consisting of the current prime rate plus 200 basis points for its finance lease.

During 2025, the parties executed two change orders primarily to amend the total contract consideration under the lease arrangement.

The Company evaluated these amendments and concluded they represented a lease modification.

As such, the finance lease ROU asset and finance lease liability were remeasured using an incremental borrowing rate at the date of the modification resulting in a decrease of approximately $ 83,000 to both the ROU asset and corresponding finance lease liability.

Operating Leases - General Office Space

The Company's lease for its corporate headquarters ( 3,169 square feet of office space) commenced in July 2018 and, as a result of an extension entered into in March 2024, expires on October 31, 2027.

The extension entered into in March 2024 resulted in additional operating lease liabilities and ROU assets of approximately $ 0.4 million in March 2024.

MBI, a wholly-owned subsidiary the Company, leases general office and laboratory space in Massachusetts.

The lease commenced on November 1, 2023 for a term of three years , expiring on December 31, 2026.

December 18, 2025, the term of the lease was extended to December 31, 2027, which resulted in additional operating lease liabilities and ROU assets of approximately $ 0.4 million.

Under the terms of each lease, the lessee pays base annual rent (subject to an annual fixed percentage increase), plus property taxes, and other normal and necessary expenses, such as utilities, repairs, and maintenance.

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The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term.

At December 31, 2024, the Company reported operating lease ROU assets of approximately $ 1.2 million in other non-current assets, approximately $ 0.5 million in current portion of lease liabilities, and approximately $ 0.8 million in lease liabilities long-term in the consolidated balance sheets.

Total operating lease costs were approximately $ 0.8 million and $ 0.6 million for the years ended December 31, 2024 and 2023, respectively.

Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the consolidated statements of operations and comprehensive loss.

Cash paid for amounts included in the measurement of operating lease liabilities was approximately $ 0.6 million and $ 0.4 million for the years ended December 31, 2024 and 2023, respectively, and these amounts are included in operating activities in the consolidated statements of cash flows.

At December 31, 2024, operating leases had a weighted average remaining lease term of 2.42 years and a weighted average interest rate of 10.50 %.

At December 31, 2024, future minimum lease payments under the Company's operating leases are as follows:

Year ending December 31,

Aggregate Lease Information

The components of lease cost recorded in the Company's consolidated statements of operations and comprehensive loss were as follows:

Operating lease cost

$ 828,036 $ 766,257

Total future minimum lease payments 1,470,000

accreted interest 167,000

Total operating lease liabilities $ 1,303,000

Finance lease cost

Amortization of finance lease

Interest on finance lease liability

Variable lease cost 124,205 172,337

Total lease cost

$ 2,577,082 $ 938,594

Maturities of the Company's finance and operating lease liabilities as of December 31, 2025 were as follows:

Operating Leases

Finance Lease

2026 $ 680,081 $ 1,529,500 $ 2,209,581

2027 583,046 — 583,046

Total lease payments

1,263,127 1,529,500 2,792,627

amount representing interest

( 101,210 ) ( 35,398 ) ( 136,608 )

Present value of lease liabilities

$ 1,161,917 $ 1,494,102 $ 2,656,019

The weighted-average remaining lease terms and discount rates related to the Company's leases were as follows:

Weighted-average remaining lease term (in years)

Operating leases

Finance lease

Weighted-average discount rate

Operating leases

Finance lease

Supplemental cash flow information related to the Company's leases was as follows:

Cash paid for amounts included in the measurement of lease liabilities

Financing cash flows from finance lease

$ 1,264,188 $ —

Operating cash flows from finance lease

$ 152,475 $ —

Operating cash flows from operating leases

$ 659,626 $ 615,325

ROYALTY INTEREST FINANCING

On December 21, 2023, the Company entered into a royalty interest financing agreement, or the Royalty Interest Agreement, with United in Endeavour, LLC, or UiE, under which UiE acquired a portion of the Company's royalty interest in XACIATO.

The Company received $ 5.0 million from UiE when the parties entered into the Royalty Interest Agreement (the "Initial Investment"), and between January 1, 2024 and December 31, 2026, the Company may, in its sole discretion, but subject to XOMA's prior written consent (see Note 13, Royalty Purchase Agreements),

elect to receive three additional payments (each a "Supplemental Investment") from UiE of up to an aggregate of $ 7.0 million, for a total of up to $ 12.0 million.

Under the Royalty Interest Agreement, the Company agreed to make the following payments to UiE, until such time when UiE has received aggregate payments equaling a 12 % internal rate of return (the “IRR”) on the Initial Investment and each Supplemental Investment, if any (the "Hard Cap"):

In December 2023, the Company entered into a royalty interest financing agreement, or the Royalty Interest Agreement, with United in Endeavour, LLC, or UiE, under which UiE acquired a portion of the Company's royalty interest in XACIATO.

The Company received $ 5.0 million from UiE when the parties entered into the Royalty Interest Agreement (the "Initial Investment"), and until December 31, 2026, the Company may, in its sole discretion, but subject to XOMA's prior written consent (see Note 13, Royalty Purchase Agreements), elect to receive three additional payments (each a "Supplemental Investment") from UiE of up to an aggregate of $ 7.0 million, for a total of up to $ 12.0 million.

Under the Royalty Interest Agreement, the Company agreed to make the following payments to UiE, until such time when UiE has received aggregate payments equaling a 12 % internal rate of return (the “IRR”) on the Initial Investment and each Supplemental Investment, if any:

(i) from December 21, 2023 through December 31, 2025, 50 % of the amount of royalty payments remaining after all amounts that are due and payable and actually paid by the Company to any licensor or sublicensee on the royalty payments generated and received by the Company on net sales of XACIATO by Organon have been deducted (the “Net Royalty Payments”), (ii) from January 1, 2026 through December 31, 2029, 75 % of the Net Royalty Payments, and (iii) from December 21, 2023 through December 31, 2029, 10 % of the amount of milestone payments remaining after all amounts that are due and payable and actually paid by the Company to any licensor or sublicensee on the milestone payments generated and received by the Company on net sales of XACIATO by Organon have been deducted.

After December 31, 2029, the Company will be required to make certain additional payments to UiE to the extent UiE has not received payments equaling the Hard Cap by December 31, 2029, December 31, 2033, and December 31, 2034, respectively.

In addition, if UiE has not received payments equaling the Hard Cap by December 31, 2035 and the Company has other sources of assets or income besides XACIATO sufficient to complete such payments, the Company has agreed to pay UiE quarterly payments evenly divided over a two-year term, such that UiE will have obtained the IRR, taking into account all other payments received by UiE from the Company under the Royalty Interest Agreement.

UiE’s right to receive payments will terminate when UiE has received payments in an amount equal to the Hard Cap.

The Company evaluated the terms of the Royalty Interest Agreement and concluded that the features of the Royalty Interest Agreement were similar to those of a debt instrument.

As a result, the Company applied the debt recognition guidance under ASC 470, Debt, and recorded the Initial Investment as a liability related to the sale of future royalties (“Royalty Obligation”) on the Company's 2023 consolidated balance sheet, which will be amortized under the effective interest method over the estimated term of the Royalty Interest Agreement.

If the Company elects to receive additional Supplemental Investments, such additional Supplemental Investments will also be recorded as a liability related to the sale of future royalties when they are received and amortized under the interest method over the estimated remaining term of the Royalty Interest Agreement.

In addition, in accordance with ASC 470, Debt, the Company will account for any royalties received in the future as non-cash royalty revenue in the consolidated statements of operations as a reduction to the debt balance.

As royalties and milestone payments are received by or on behalf of the Company from Organon and the Company subsequently pays or causes to be paid the amounts due to UiE in respect thereof in accordance with the Royalty Interest Agreement, the Royalty Obligation will be effectively repaid during the term of the Royalty Interest Agreement.

In order to determine the amortization of the Royalty Obligation, the Company is required to estimate the total amount of future payments to UiE during the term of the Royalty Interest Agreement.

At execution of the Royalty Interest Agreement, the Company’s estimate of this total interest expense resulted in an effective annual interest rate of approximately 22.48 %.

This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the royalty period.

The Company will periodically assess the estimated amounts due and payable to UiE and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense.

There are a number of factors that could materially affect XACIATO's commercial success, and therefore the amount and timing of the Company's payments to UiE, and correspondingly, the amount of interest expense recorded by the Company, most of which are not within the Company’s control.

After December 31, 2029, the Company will be required to make certain additional payments to UiE to the extent UiE has not received payments equaling the IRR by December 31, 2029, December 31, 2033, and December 31, 2034, respectively.

In addition, if UiE has not received payments equaling the IRR by December 31, 2035 and the Company has other sources of assets or income (besides XACIATO) sufficient to complete such payments, the Company has agreed to pay UiE quarterly payments evenly divided over a two-year term ("Catch-up Payments"), such that UiE will have obtained the IRR, taking into account all other payments received by UiE from the Company under the Royalty Interest Agreement.

UiE’s right to receive payments will terminate when UiE has received payments in an amount equal to the IRR (such period of time is referred to as the "Financing Term").

Under the Royalty Interest Agreement, the Company has the right, at any time and from time to time, to make voluntary prepayments to UiE, and such payments will be credited against the IRR.

In addition, the Company has the right at any time to pay in full and retire all of the Company's payment obligations to UiE by paying the full amount of the IRR (the "Call Payment"), calculated as of the date of the payment.

The Company evaluated the terms of the Royalty Interest Agreement and concluded that its features were similar to those of a debt instrument.

As a result, the Company applied the debt recognition guidance under ASC 470, Debt, and recorded the Initial Investment as a liability related to the sale of future royalties, which will be amortized under the effective interest method over the estimated Financing Term.

If the Company elects to receive additional Supplemental Investments, such additional Supplemental Investments will also be recorded as a liability related to the sale of future royalties when they are received and amortized under the interest method over the estimated remaining Financing Term.

In addition, in accordance with ASC 470, Debt, any royalties and milestone payments received by or on behalf of the Company from Organon from and after the date of the Initial Investment are recorded as non-cash royalty revenue in the consolidated statements of operations as a reduction to the liability related to the sale of future royalties.

To determine the amortization of the liability related to the sale of future royalties, the Company is required to estimate the duration of the Financing Term and the total amount of future payments to UiE during the Financing Term.

These estimates involve significant estimates and assumptions regarding future Net Royalty Payments that impact both the amount of the liability related to the sale of future royalties and the interest expense that will be recognized over the Financing Term.

The Company will periodically reassess the estimated amounts due and payable to UiE and the duration of the Financing Term and to the extent the estimated amount or timing of such payments is materially different than the prior estimate, an adjustment will be recorded in future periods, prospectively to increase

or decrease interest expense.

There are a number of factors that could materially affect XACIATO's commercial success, and therefore the amount and timing of the Company's payments to UiE, and correspondingly, the amount of interest expense and interest payable recorded by the Company, most of which are not within the Company’s control.

Such factors include, but are not limited to, the capabilities of Organon and its commitment of sufficient resources to market, distribute and sell the product;

timely and adequate commercial supply of the finished product and its components;

perceived superiority of its cure rates compared to other available treatments;

patient satisfaction and willingness to use it again and refer it to others;

timely and adequate commercial supply of XACIATO and its components;

perceived superiority of XACIATO's cure rates compared to other available treatments;

patient satisfaction and willingness to use XACIATO again and refer it to others;

price pressure given the high level of generic treatments and changes in health care laws and regulations;

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and approval of new entrants, including alternative, non-antibiotic treatment options.

These factors could result in increases or decreases to both royalty revenues and interest expense.

In connection with entering into the Royalty Interest Agreement, the Company issued to UiE a warrant (the “Initial Royalty Warrant”) to purchase up to 422,804 shares of the Company’s common stock.

In addition, for every $ 1,000,000 of Supplemental Investment, the Company will issue a warrant to purchase 84,561 shares of common stock, for an aggregate of warrants to purchase up to 591,927 shares of common stock (collectively the “Additional Royalty Warrants,” and together with the Initial Royalty Warrant, the “Royalty Interest Agreement Warrants”).

The Royalty Interest Agreement Warrants are exercisable, in full or in part, at any time on or prior to the fifth anniversary of their issuance date at an exercise price of $ 4.10 per share, subject to customary anti-dilution adjustments.

The Royalty Interest Agreement Warrants may be exercised for cash, or if at the time of exercise there is no effective registration statement registering for resale the shares underlying the Royalty Interest Agreement Warrants, then in lieu of paying the exercise price in cash, the holders may elect to exercise on a cashless basis.

The Royalty Interest Agreement Warrants were deemed to be equity classified warrants and recorded under additional paid in capital.

These factors could result in increases or decreases to the length of the Financing Term and the total amount owed to UiE.

During the year ended December 31, 2025, based on Net Royalty Payments to date and other factors, the Company updated its forecast of Net Royalty Payments, resulting in an estimated Financing Term that is approximately 9.5 years longer than previously estimated, extending through 2037, and as of December 31, 2025, the effective interest rate on the liability related to the sale of future royalties is 12.8 %.

Under the current estimated Financing Term, the estimated total amount potentially owed to UiE would be approximately $ 22.0 million, substantially all of which would be paid as Catch-up Payments.

However, as discussed above, the Company has the right to make voluntary prepayments to UiE that would be credited against the IRR, as well as the right to make the Call Payment, either of which actions could reduce the total amount owed to UiE, potentially materially.

In connection with entering into the Royalty Interest Agreement, the Company issued to UiE a warrant (the “Initial Royalty Warrant”) to purchase up to 422,804 shares of the Company’s common stock (see Note 9, Stockholders' Equity).

In addition, for every $ 1.0 million of Supplemental Investment, the Company will issue to UiE a warrant to purchase 84,561 shares of common stock.

If the Company elects to receive the maximum amount of Supplement Investments, the Company would issue to UiE warrants to purchase an aggregate of up to 591,927 shares of common stock (collectively the “Additional Royalty Warrants,” and together with the Initial Royalty Warrant, the “Royalty Interest Agreement Warrants”).

As of December 31, 2025, the Company has only issued the Initial Royalty Warrant.

The Initial Royalty Warrant was deemed to be an equity classified warrant and recorded under additional paid in capital.

The fair value of the Initial Royalty Warrant was determined to be $ 0.8 million (Note 9) and was recorded as a debt discount against the Initial Investment.

The following table shows the activity of the Royalty Obligation since the transaction inception through the period indicated:

December 31, 2024

The following table shows the activity of the liability related to the sale of future royalties since the date of the Initial Investment through the period indicated:

Upfront payment from the sale of future royalties $ 5,000,000 $ 5,000,000

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ROYALTY PURCHASE AGREEMENTS

On April 29, 2024, the Company entered into a traditional royalty purchase agreement (the "XACIATO RPA"), and a synthetic royalty purchase agreement, (the "Synthetic RPA and together with the XACIATO RPA, the “Royalty Purchase Agreements”) with XOMA pursuant to which XOMA paid $ 22.0 million to the Company.

In April 2024, the Company entered into a traditional royalty purchase agreement (the "XACIATO RPA"), and a synthetic royalty purchase agreement (the "Synthetic RPA and together with the XACIATO RPA, the “Royalty Purchase Agreements”) with XOMA pursuant to which XOMA paid $ 22.0 million to the Company.

In addition, if XOMA receives total payments under the Royalty Purchase Agreements (as described below) equal to an amount that exceeds $ 88.0 million, XOMA will pay $ 11.0 million to the Company for each successive $ 22.0 million XOMA receives under the Royalty Purchase Agreements (such $ 11.0 million payments to the Company, the “Contingent Purchase Price Payments”).

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(a) 100 % of the royalties and potential milestone payments the Company would otherwise have the right to receive from and after April 1, 2024 under the Company's exclusive license agreement with Organon, based on net sales of XACIATO, net of (i) all royalty and milestone payments due and payable and actually paid by or on behalf of the Company under its exclusive license agreement with third-party licensors TriLogic and MilanaPharm, and (ii) all payments due and payable and actually paid by or on behalf of the Company under the Royalty Interest Agreement between the Company and UiE (such net amount, the “Purchased Receivables”);

(b) 25 % of the potential future $ 20.0 million payment that the Company would otherwise have the right to receive under the Company's license agreement with Bayer, if Bayer, in its sole discretion, elects to make the license granted thereunder effective following completion of the pivotal clinical trial of Ovaprene;

(c) a synthetic royalty of 4.0 % of the Company's, its affiliates’ and its sublicensees’ future net sales of the Company's investigational product Ovaprene, and 2.0 % of the Company's, its affiliates’ and its sublicensees’ future net sales of the Company's investigational product Sildenafil Cream, 3.6 %;

provided, however , that, if XOMA receives total payments under the Royalty Purchase Agreements, net of any Contingent Purchase Price Payments made to the Company, equal to an amount that exceeds $ 110.0 million, the foregoing percentages will be reduced to 2.5 % and 1.25 %, respectively (such amounts described in the foregoing clauses (b) and (c), collectively, the “Revenue Participation Right”).

(b) 25 % of the $ 20.0 million payment that the Company could have potentially received under the Company's since terminated license agreement with Bayer relating to Ovaprene;

(c) a synthetic royalty of 4.0 % of the Company's, its affiliates’ and its sublicensees’ future net sales of Ovaprene, and 2.0 % of the Company's, its affiliates’ and its sublicensees’ future net sales of Sildenafil Cream and DARE to PLAY™ Sildenafil Cream;

provided, however , that, if XOMA receives total payments under the Royalty Purchase Agreements, net of any Contingent Purchase Price Payments made to the Company, equal to an amount that exceeds $ 110.0 million, the foregoing percentages will be reduced to 2.5 % and 1.25 %, respectively (we refer to the amounts described in this clause (c) as the “Revenue Participation Right”).

Pursuant to the XACIATO RPA, XOMA, at its sole cost and discretion, may repay in full and retire all of the Company's payment obligations to UiE under the Royalty Interest Agreement.

If XOMA does so, no further amounts in respect of the Royalty Interest Agreement will be deducted from the net royalties and net milestone payments that XOMA is entitled to receive under the XACIATO RPA.

As of April 29, 2024, the Company cannot elect to receive any additional funding from UiE under the Royalty Interest Agreement without XOMA’s prior written consent.

In connection with the synthetic royalty purchase agreement, the Company granted to XOMA a security interest in certain product assets related to Ovaprene and Sildenafil Cream.

The Company cannot elect to receive any additional funding from UiE under the Royalty Interest Agreement without XOMA’s prior written consent.

In connection with the synthetic royalty purchase agreement, the Company granted to XOMA a security interest in certain product assets related to Ovaprene, Sildenafil Cream and DARE to PLAY.

The $ 22.0 million the Company received from XOMA, less transaction costs of approximately $ 1.6 million, was allocated to the XACIATO RPA and recorded as other income on the Company's consolidated statement of operations and comprehensive loss in the second quarter of 2024.

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In each of July 2025 and 2024, the Company obtained financing for certain director and officer and other insurance premiums.

The total premiums, taxes and fees financed each year was approximately $ 0.6 million with an annual interest rate of approximately 8.0 %.

The total premiums, taxes and fees financed each year was approximately $ 0.5 million and $ 0.6 million, respectively, with an annual interest rate of approximately 8.0 %.

In consideration of the premium payment by the lender to the insurance companies or the agent or broker, the Company unconditionally promised to pay the lender the amount financed plus interest and other charges permitted under the agreements and the Company assigned to the lender a first priority lien on and a security interest in the financed insurance policies.

With respect to the financing obtained in July 2024, the Company will make monthly installment payments through April 20, 2025.

With respect to the financing obtained in July 2025, the Company will make monthly installment payments through March 20, 2026.

With respect to the financing obtained in July 2024, the Company made monthly installment payments through April 20, 2025.

The financed amount is recognized as an insurance financing cost included in other current assets and accrued expenses in the Company's consolidated balance sheets.

As of December 31, 2024, the Company's remaining obligation for the financing obtained in July 2024 was approximately $ 0.2 million.

As of December 31, 2025, the Company's remaining obligation for the financing obtained in July 2025 was approximately $ 0.2 million, and the Company had no remaining obligation for the financing obtained in July 2024.

As of December 31, 2024, the Company's remaining obligation for the financing obtained in July 2024 was approximately $ 0.2 million.

The Company had no remaining obligations for the financing obtained in July 2023 as of December 31, 2024.

CRADA with NICHD for the Pivotal Phase 3 Study of Ovaprene

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NICHD is responsible for the other costs related to the conduct of the Ovaprene Phase 3.

The Company made aggregate payments of $ 5.5 million to NICHD, $ 0.5 million of which was paid in July 2024 and $ 5.0 million of which was paid in prior years.

The Company had no remaining obligation under the CRADA at December 31, 2024.

The Company has paid $ 5.5 million to NICHD, $ 0.5 million of which was paid in July 2024 and

$ 5.0 million of which was paid in prior years.

The Company had no remaining payment obligation under the CRADA at December 31, 2025.

Legal Proceedings

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If their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company, such executives will be entitled to receive a payment of an amount equal to either nine or eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between nine and eighteen months following the termination of employment.

upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement.

In addition, upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement.

Related-Party Agreement

On January 26, 2024, the Company entered into a consulting agreement with its former Chief Financial Officer to assist in transition matters subsequent to her retirement.

In January 2024, the Company entered into a consulting agreement with its former Chief Financial Officer to assist in transition matters subsequent to her retirement.

Pursuant to the agreement, for a nine month period commencing on January 26, 2024, the Company paid its former Chief Financial Officer $ 31,667 per month and reimbursed her up to $ 500 per month for her health insurance premiums.

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The 401(k) Plan includes a Safe Harbor Plan that provides a Company match up to 4 % of each participant's cash compensation.

The Company made matching contributions of approximately $ 0.2 million and $ 0.2 million during the years ended December 31, 2024 and 2023, respectively.

The Company made matching contributions of approximately $ 0.2 million during each of the years ended December 31, 2025 and 2024.

October 2024 Grant Award

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d/b/a VentureWell (the "CMF") under which the Company is entitled to receive funding of up to $ 10.0 million in milestone-based payments subject to the Company's achievement over an approximately 24-month period of specified research activities and objectives relating to the advancement of the Company's DARE-HPV development program, including commencement of a Phase 2 clinical study to evaluate the safety and preliminary efficacy of DARE-HPV for the clearance of high-risk HPV infection in women.

The subaward agreement was the result of the Company's selection by an agency within the U.S.

The subaward agreement was the result of the Company's selection by Advanced Research Projects Agency for Health (ARPA-H), part of the U.S.

Department of Health and Human Services.

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The Company receives funding in advance and tracks and reports eligible expenses incurred to the federal agency.

The Company is required to apply the funds it receives solely toward direct costs for the funded project, other than approximately 22 % of such funds, which it may apply toward general overhead and administrative expenses that support the entire operations of the Company.

Funds received that have not been spent are recorded as cash and cash equivalents and as a deferred grant funding liability in the Company’s consolidated balance sheets.

The deferred grant funding liability also includes grant funds spent but not yet expensed in accordance with GAAP.

The Company must track expenses incurred under the award and submit a detailed accounting of such expenses.

Through December 31, 2024, the Company received one payment of $ 1.0 million under this award.

The Company recorded credits to research and development expense of approximately $ 0.4 million for costs related to this award for the year ended December 31, 2024.

As of December 31, 2024, the Company has recorded approximately $ 0.6 million of deferred grant funding liability in the Company's consolidated balance sheets.

The Company is required to apply the funds it receives solely toward direct costs for the funded project, other than an approximately 22 % indirect cost allowance.

An "indirect cost allowance" refers to the portion of the grant funds the Company receives that it may apply toward general overhead and administrative expenses that support the entire operations of the Company and which may be applied as the direct costs for the funded project are incurred.

Funds received that have not been spent are recorded both in cash and cash equivalents and in deferred grant funding

liability in the Company’s consolidated balance sheets.

Funds that have been spent but not yet expensed in accordance with GAAP or not spent on direct costs for the funded project in excess of the indirect cost allowance are also recorded in deferred grant funding liability.

Through December 31, 2025, the Company had received payments totaling $ 5.5 million under this award.

The Company recorded credits to research and development expense of approximately $ 3.1 million and $ 0.4 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025 and 2024, the Company recorded approximately $ 2.0 million and $ 0.6 million in deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.

See Note 17, Subsequent Events, for information regarding a payment received in February 2026 under this award.

NICHD and NIH Non-Dilutive Grant Funding

The Company has received notices of awards and non-dilutive grant funding from the NICHD and the National Institutes of Health, or NIH, to support the development of several of its product candidates.

The NICHD and NIH issue notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment.

The Company has received notices of awards and grant funding from NICHD and the National Institutes of Health, or NIH, to support the development of several of its product candidates.

NICHD and the NIH issue notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment.

If the Company receives payments under the award, the amounts of such payments are recognized in the statements of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period.

The federal agency that administers funding to the NIH is the Small Business Innovation Research (SBIR).

In October 2025, legislative authority for the SBIR program expired and, to date, it has not been reauthorized by Congress.

In November 2025, NIH announced that it will not issue continuation awards for existing projects until the SBIR program is reauthorized.

As a result of this funding freeze, the Company currently does not anticipate receiving additional funding under this award until and unless the SBIR program is reauthorized by Congress.

In December 2024, the Company received a notice of award from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, that the Company was awarded a $ 1.0 million grant in support of non-clinical activities for the development of DARE-HPV for an initial project year of December 2024 through November 2025, and that an additional $ 1.0 million was recommended for the subsequent project year, subject to the availability of funds and satisfactory progress of the project, as determined by NIAID.

The Company recorded no credits to research and development expense for costs related to the NIH award for the year ended December 31, 2024 and recorded no receivable at December 31, 2024.

In August 2020, the Company received a notice of award from NICHD to support the development of DARE-PTB1.

The award of approximately $ 0.3 million was used for what was referred to as the "Phase I" segment of the project outlined in the Company's grant application, which ended in July 2023.

The Company received aggregate reimbursements under the award of approximately $ 0.2 million during the grant period which ended in July 2023.

No further funds are available under this award for the Phase I segment.

In December 2023, the Company received a notice of award of approximately $ 2.0 million for the "Phase II" segment of the project.

The Company recorded credits to research and development expense for costs related to the NICHD award of approximately $ 0.7 million for the year ended December 31, 2024.

The Company recorded a receivable of approximately $ 0.1 million at December 31, 2024 for expenses incurred through such date that it believes are eligible for reimbursement under the grant.

In September 2021, the Company received a notice of award from NICHD to support the development of DARE-LARC1.

The award in the amount of approximately $ 0.3 million was used to explore device insertion and removal in nonclinical studies.

The Company recorded credits to research and development expense of approximately $ 32,000 for costs related to the NICHD award for the year ended December 31, 2023.

The Company received aggregate reimbursements under the NICHD award of approximately $ 0.3 million during the grant period, which ended in June 2023.

No further funds are available under this award.

DARE-204 and DARE-214

In May 2022, the Company received a notice of award from NICHD of approximately $ 0.2 million to support end-user research to better understand women's preferences for a long-acting injectable contraceptive method.

The findings from the research will inform the Company's target product profile and guide its development priorities for DARE-204 and DARE-214.

The Company recorded credits to research and development expense of approximately $ 0.1 million for costs related to the NICHD award for the year ended December 31, 2023.

The Company received aggregate reimbursements under the NICHD award of approximately $ 0.2 million during the grant period, which ended in September 2023.

No further funds are available under this award.

The Company recorded $ 0.7 million and $ 0 credits to research and development expense for costs related to the NIH award for the years ended December 31, 2025 and 2024, respectively.

The Company recorded a receivable of approximately $ 11,000 at December 31, 2025 for expenses incurred through such date that it believes are eligible for reimbursement under this award.

In December 2023, the Company received a notice of award from NICHD of approximately $ 2.0 million to support the development of DARE-PTB1.

The award is to be used to support what is referred to as the "Phase II" segment of the project outlined in the Company's grant application through November 2026.

The Company recorded credits to research and development expense for costs related to this award of approximately $ 0.7 million and $ 0.7 million for the years ended December 31, 2025 and 2024, respectively.

The Company recorded a receivable of $ 0 and approximately $ 84,000 at December 31, 2025 and 2024, respectively, for expenses incurred through such date that it believes are eligible for reimbursement under this award.

In July 2023, the Company received a notice of award from NICHD of approximately $ 0.4 million to support preclinical development of a potential new therapeutic for the prevention of idiopathic preterm birth.

The grant funds will support activities related to the conduct and completion of proof-of-concept target validation studies in collaboration with the University of South Florida, which are to occur over a 12-month period.

The Company recorded credits to research and development expense of approximately $ 0.3 million and $ 0.1 million for costs related to the NICHD award for the year ended December 31, 2024 and 2023, respectively.

The Company received aggregate reimbursements under the NICHD award of approximately $ 0.4 million during the grant period, which ended in July 2024.

The grant funds supported activities related to the conduct and completion of proof-of-concept target validation studies in collaboration with the University of South Florida.

The Company received aggregate reimbursements under this award of approximately $ 0.4 million during the grant period, which ended in July 2024.

No further funds are available under this award.

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As described below, the Company has received substantial funding under grant agreements it entered into with the Gates Foundation, or the Foundation.

The Company is required to apply the funds it receives under the agreements solely toward direct costs for the applicable funded projects, other than approximately 5 %- 15 % of such funds, which it may apply toward general overhead and administrative expenses that support the entire operations of

The Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation.

Funds received that have not been spent are recorded as cash and cash equivalents and as a deferred grant funding liability in the Company’s consolidated balance sheets.

The deferred grant funding liability also includes grant funds spent but not yet expensed in accordance with GAAP.

The Company is required to apply the funds it receives solely toward direct costs for the funded projects, other than an approximately 5 %- 15 % indirect cost allowance (see "October 2024 Grant Awards" for more information regarding the indirect cost allowance).

Funds received that have not been spent are recorded both in cash and cash equivalents and in deferred grant funding liability in the Company’s consolidated balance sheets.

Funds spent but not yet expensed in accordance with GAAP or not spent on direct costs for the funded project in excess of the indirect cost allowance are also recorded in deferred grant funding liability.

The grant agreements include the Foundation's standard discretionary termination provisions.

Any grant funds that have not been used or committed to the funded project must be returned promptly to the Foundation upon expiration or termination of the agreement.

Any grant funds received that have not been committed to the funded project or spent in compliance with the applicable grant agreement must be returned promptly to the Foundation upon expiration or termination of the agreement.

2024 Contraceptive Product Candidate Grant Agreement

In November 2024, the Company entered into a grant agreement with the Foundation under which the Company was awarded a new grant of up to approximately $ 10.7 million to support (i) expansion of the number of study sites in the ongoing Phase 3 clinical trial of Ovaprene, and (ii) activities that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive candidate, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

An initial payment of approximately $ 5.4 million was made to the Company in November 2024.

Additional payments are contingent upon the Company's achievement of specified development and reporting milestones during the term of the grant agreement, which extends through October 2026.

In November 2024, the Company entered into a grant agreement with the Foundation under which the Company was awarded a grant of up to approximately $ 10.7 million to support (i) expansion of the number of study sites in the ongoing Phase 3 clinical trial of Ovaprene, and (ii) activities that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive candidate, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

The term of the agreement, as amended, extends through March 2027.

An initial payment of approximately $ 5.4 million was made to the Company in November 2024 and a second payment of approximately $ 3.6 million was made to the Company in November 2025.

Additional payments are contingent upon the Company's achievement of specified development and reporting milestones during the term of the grant agreement.

The Company will track and report eligible expenses incurred to the Foundation.

The Company recorded credits to research and development expense of approximately $ 0.2 million for costs related to this award for the year ended December 31, 2024.

As of December 31, 2024, the Company has recorded approximately $ 5.2 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets.

The Company recorded credits to research and development expense of approximately $ 3.7 million and $ 0.2 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025 and 2024, the Company recorded approximately $ 5.1 million and $ 5.2 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.

2024 Biotherapeutic Product Grant Agreement

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The Company recorded credits to research and development expense of approximately $ 0.7 million for costs related to this award for the year ended December 31, 2024.

As of December 31, 2024, the Company has recorded approximately $ 39,000 of deferred grant funding liability related to this award in the Company's consolidated balance sheets.

The grant period ended in November 2024.

No further funds are available under this award.

2021 DARE-LARC1 Grant Agreement

In June 2021, the Company entered into an agreement with the Foundation under which the Company was awarded up to approximately $ 49.0 million to support the development of DARE-LARC1.

The agreement supports technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 through nonclinical proof-of-principle studies and other IND-enabling work to allow for the submission of an IND application with the FDA, approval of which will be required to commence testing in humans.

As of December 31, 2024, the Company has received a cumulative total of approximately $ 31.8 million in non-dilutive funding under the agreement, including $ 4.5 million during 2023 and $ 3.5 million during 2024.

The term of the agreement, as amended, extends through December 2027.

The agreement supports technology development and preclinical activities to advance DARE-LARC1 through nonclinical proof-of-principle studies and other IND-enabling work to allow for the submission of an IND application with the FDA, approval of which will be required to commence testing in humans.

As of December 31, 2025, the Company had received a cumulative total of approximately $ 41.8 million in funding under the agreement.

Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones.

The Company recorded credits to research and development expense of approximately $ 6.2 million and $ 8.7 million for costs related to this award for the year ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, the Company recorded approximately $ 10.8 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets.

The Company recorded credits to research and development expense of approximately $ 8.2 million and $ 6.2 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025 and 2024, the Company recorded approximately $ 12.6 million and $ 10.8 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.

2022 DARE-LBT Grant Agreement

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The Company received the full amount of the award in November 2022.

The Company recorded credits to research and development expense of approximately $ 0.2 million and $ 0.3 million for costs related to this award for the year ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, the Company had no deferred grant funding liability related to this award in the Company's consolidated balance sheets.

The Company recorded credits to

research and development expense of approximately $ 0.2 million for costs related to this award for the year ended December 31, 2024.

The Company had no remaining deferred grant funding liability related to this award as of December 31, 2024.

SEGMENT INFORMATION

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Year Ended December 31,

License fee revenue

License fee and other revenues

$ 1,030,193 $ 9,784

Milestone revenue

Royalty revenue

Total revenue

1,030,193 9,784

Cost of revenues

Segment operating expenses:

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Other development programs

27,542 189,706

Contra-R&D expenses (3)

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2,564,460 4,666,281

General and administrative

9,156,061 12,109,691

Other operating expenses

Selling, general and administrative

8,763,376 9,156,061

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$ ( 13,399,274 ) $ ( 4,053,599 )

(1) The applicable program(s) receive grant funding and/or the Tax Incentive.

The amount of R&D expense for the period indicated is shown on a gross basis (i.e., without deducting the amount of contra R&D expense for the applicable program(s).

See footnote (3) below.

(2) For 2025, the dollar amount also includes expenses for DARE to PLAY.

(3) These contra R&D expenses were recognized as follows for the years ended December 31, 2025 and 2024:

(a) Ovaprene, $ 2.5 million, and $ 0.2 million, respectively;

(b) Other advanced clinical stage programs, $ 2.9 million and $ 0 , respectively, (c) Phase 1 and Phase 1-ready clinical stage programs, $ 0.4 million and $ 1.3 million, respectively;

and (d) Preclinical stage programs, $ 8.1 million and $ 6.2 million, respectively.

SUBSEQUENT EVENTS

Noncompliance with Nasdaq’s Minimum Market Value of Listed Securities Requirement

On August 12, 2024, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) notifying it that it did not meet the requirement in Nasdaq Listing Rule 5550(b)(2) for continued listing on The Nasdaq Capital Market.

Nasdaq Listing Rule 5550(b)(2) requires a company listed on Nasdaq to maintain a minimum market value of listed securities of $35.0 million (the “Minimum MVLS Rule”).

The Company was provided an initial period of 180 calendar days, or until February 10, 2025, to regain compliance with the Minimum MVLS Rule.

On February 13 , 2025, Nasdaq’s Listing Qualifications Department notified the Company that because it did not regain compliance with the Minimum MVLS Rule by February 10, 2025, its common stock is subject to delisting from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearing Panel (the “Panel”).

On February 20, 2025, the Company requested a hearing before the Panel, which request stayed the delisting of its common stock pending the decision of the Panel following the hearing and the expiration of any extension period that may be granted by the Panel.

The hearing occurred on March 25, 2025.

Pursuant to published Nasdaq guidance, the Panel typically issues it decision within 30 days of the hearing.

There can be no assurance that the Panel will grant the Company any extension period within which to regain compliance with the Minimum MVLS Rule, or if any extension period is granted, that the Company will regain compliance with the Minimum MVLS Rule within such extension period, or that the Company will be successful in otherwise maintaining the listing of our common stock on The Nasdaq Capital Market.

Receipt of Payment Under October 2024 Grant Award

On February 19, 2026, the Company received a $ 2.0 million payment from CMF under the agreement the Company entered into with CMF in October 2024 to support the development of DARE-HPV.

For a discussion of this agreement, see Note 15, Grant Awards.

Taking into account this payment, the Company has received a cumulative total of approximately $ 7.5 million of the up to $ 10.0 million in potential funding under this award.

Designation of Series A Preferred Stock

On January 23, 2026, in anticipation of the initial closing of its Regulation A offering (see “—Regulation A Offering,” below), the Company filed a Certificate of Designation of Series A Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware, which became effective upon filing.

The Certificate of Designation designates 4,999,620 shares of the Company’s authorized preferred stock, $ 0.01 par value per share, as Series A Convertible Preferred Stock (the “Series A Preferred Stock”) and establishes the following powers, preferences and rights, and qualifications, limitations and restrictions of such series of preferred stock:

Voting Rights .

Except as required by law, the Series A Preferred Stock has no voting rights.

The Series A Preferred Stock ranks, as to rights upon liquidation, dissolution, or winding up, senior to the Company’s common stock.

The terms of the Series A Preferred Stock do not limit the Company’s ability to (i) incur indebtedness or (ii) issue additional equity securities that are senior in rank to the Series A Preferred Stock as to dividend or distribution rights and rights upon liquidation, dissolution or winding up.

Stated Value .

Each share of the Series A Preferred Stock has an initial stated value of $ 5.00 , subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events affecting the Series A Preferred Stock.

Dividend Rights .

Holders of the Series A Preferred Stock are not entitled to receive any dividends.

Liquidation Preference .

The liquidation preference for each share of the Series A Preferred Stock is $ 5.00 per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events affecting the Series A Preferred Stock.

Upon the Company’s liquidation, dissolution or winding up, to the extent the Company has the cash available, holders of shares of the Series A Preferred Stock will be entitled to receive the liquidation preference with respect to their shares of Series A Preferred Stock.

Company Call Option .

Commencing on the third anniversary of the initial closing of the Regulation A offering and continuing indefinitely thereafter, the Company will have a right to call for redemption the outstanding shares of the Series A Preferred Stock at a per share call price equal to the lesser of (i) the stated value per share plus a non-compounded rate of return calculated at 8 % per annum, and (ii) 200 % of the stated value per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events affecting the Series A Preferred Stock.

Conversion at Option of Holder .

At any time after issuance, each share of the Series A Preferred Stock is convertible at the option of the holder thereof into shares of the Company’s common stock at a conversion price of $ 2.50 per share (the “Initial Conversion Price”), subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.

Accordingly, each share of the Series A Preferred Stock is initially convertible into two shares of the Company’s common stock.

Forced Conversion .

If at any time after issuance, any of the following events occurs, the Company will have the right to require the holders of shares of Series A Preferred Stock to convert all, or any portion of, their shares of Series A Preferred Stock into shares of the Company’s common stock:

(a) a change in control, (b) if the closing price of the Company’s common stock is at or above $ 4.50 per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events, for any 10 trading days out of any 30 consecutive trading day period, or (c) if the Company consummates a firm commitment public offering of shares of the Company’s common stock resulting in gross proceeds of at least $ 15.0 million at an offering price per share equal to or greater than $ 4.50 , subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.

Limitations on Conversion .

Notwithstanding the conversion rights described above, to the extent prohibited by applicable rules of The Nasdaq Stock Market LLC or any other national securities exchange or trading market on which the Company’s capital stock is listed, the Company will not issue shares of Common Stock upon conversion of shares of Series A Preferred Stock if such issuance will result in a change of control of the Company under Nasdaq Listing Rule 5635(b) or would violate Nasdaq Listing Rule 5635(d), in each case, unless the Company obtains stockholder approval of such issuance in accordance with such applicable rules.

As it applies to the Regulation A offering, Nasdaq Listing Rule 5635(d) generally provides that if the initial conversion price of the Series A Preferred Stock is less than the “Minimum Price” (as such term is defined in Nasdaq Listing Rule 5635(d)) plus $0.125 (with such amount added to account for the valuation, under the Nasdaq Listing Rules, of the warrants issued as part of the units in the Offering), stockholder approval is required prior to the issuance of shares of the Company’s common stock in the offering that equals or exceeds 20% or more of the total number of shares of the Company’s common stock outstanding as of immediately prior the initial closing the offering.

For additional information regarding the applicability of Nasdaq Listing Rule 5635(d), see “Regulation A Offering—Initial Closing,” below.

No Redemption Right .

The Series A Preferred Stock has no maturity date, and the Company is not required to redeem any of the Series A Preferred Stock at any time.

Regulation A Offering

On January 27, 2026, the Company completed the initial closing of its Regulation A offering of up to 4,854,000 units (each, an “Investor Unit” and collectively the “Investor Units”), each consisting of one share of Series A Preferred Stock and two warrants, each to purchase one share of the Company’s common stock (“Investor Warrants”), with each Investor Unit being offered at an offering price of $ 5.00 (the “Regulation A offering”).

The closing price of the Company’s common stock on January 26, 2026, was $ 1.90 , and because the Initial Conversion Price exceeded the sum of that closing price plus $0.125, the limitations under Nasdaq Listing Rule 5635(d) that could have applied to the conversion of the Series A Preferred Stock and to the exercise of the Investor Warrants issued in the Regulation A offering will not apply to any of the shares of Series A Preferred Stock or the Investor Warrants that are part of the up to 4,854,000 Investors Units that may be issued in the Regulation A offering.

The Regulation A offering is being conducted pursuant to the Company’s offering statement on Form 1-A (File No.

024-12688), as amended (the “Offering Statement”), which was qualified by the SEC on January 5, 2026, and the offering circular, dated January 6, 2026, which forms a part thereof (the “Offering Circular”).

The Regulation A offering is being conducted on a “best efforts” basis pursuant to a selling agency agreement, dated January 5, 2026 (the “Selling Agency Agreement”), between the Company and Digital Offering, LLC (“Digital Offering”), acting as the lead selling agent for the Regulation A offering.

Digital Offering is not required to sell any specific number or dollar amount of Investor Units.

The Company will pay to Digital Offering a placement fee equal to 7.25 % of the offering price per Investor Unit sold in the Regulation A offering.

The Company will also issue Agent Unit Warrants (as defined below) to purchase that number of Agent Units (as defined below) equal to 3 % of the total number of Investor Units sold in the Regulation A offering.

In addition, the Company paid Digital Offering a $ 25,000 consulting fee and reimbursed or will reimburse Digital Offering for up to $ 85,000 of its reasonable, out-of-pocket, and documented fees and expenses incurred in connection with the Regulation A offering.

The Investor Warrants are exercisable at any time after issuance through the 36-month anniversary of their date of issuance at an exercise price of $ 4.00 per share of the Company’s common stock, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.

Notwithstanding the foregoing, there are certain limitations on the exercise of the Investor Warrants to the extent a holder (together with its affiliates) would own more than 4.99 % (or 9.99 %) of the outstanding the Company’s common stock immediately after exercise.

The Regulation A offering will terminate at the earliest of (i) the date on which the maximum offering amount of Investor Units has been sold, (ii) January 5, 2027 (one year after the date on which the Offering Statement was qualified by the SEC) and (iii) the date on which the Company determines to terminate the Regulation A offering, which the Company may do in its sole discretion at any time and for any reason or no reason.

The Offering Circular also relates to (i) 145,620 warrants (the “Agent Unit Warrants”) to purchase up to 145,620 units (the “Agent Units”) issuable to the selling agent(s) for the Regulation A offering, each Agent Unit consisting of one share of Series A Preferred Stock and two warrants, each to purchase one share of the Company’s common stock, (ii) up to 145,620 shares of Series A Preferred Stock issuable upon exercise of the Agent Unit Warrants and up to 291,240 shares of the Company’s common stock issuable upon conversion of such shares of Series A Preferred Stock, and (iii) up to 291,240 warrants (the “Agent Common Warrants”) issuable upon exercise of the Agent Unit Warrants and up to 291,240 shares of the Company’s common stock issuable upon exercise of the Agent Common Warrants.

The Company will issue Agent Unit Warrants to purchase that number of Agent Units equal to 3 % of the total number of Investor Units sold in the Regulation A offering.

The exercise price per Agent Unit Warrant is $ 6.25 , subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.

The Agent Unit Warrants will expire on January 7, 2031, which is the five-year anniversary of the date of commencement of sales in the Regulation A offering.

The exercise price per Agent Common Warrant is $ 4.00 per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.

The terms of the Agent Common Warrant are substantially similar to the terms of the Investor Warrant, except that they expire on January 7, 2031.

As of the filing date of this report, the Company has issued an aggregate of 65,640 Investor Units consisting of 65,640 shares of Series A Preferred Stock and Investor Warrants to purchase up to 131,280 shares of the Company’s common stock, for gross proceeds of approximately $ 328,200 , and 1,968 Agent Units.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.